An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.
Mike Segar | Reuters
The Alzheimer’s treatment donanemab, which is made by Eli Lilly, significantly slowed progression of the mind-robbing disease, according to clinical trial data released Wednesday by the company.
Patients who received the monthly antibody infusion during an 18-month study demonstrated a 35% slower decline in memory, thinking and their ability to perform daily activities compared with those who did not receive the treatment, Eli Lilly’s data showed.
Patients who took donanemab were 39% less likely to progress to the next stage of the disease during the study, according to the trial results.
But the treatment’s benefits will have to be weighed against the risk of brain swelling and bleeding that can be serious and even fatal in rare cases. Three participants in the trial died from these side effects.
Eli Lilly’s stock was up more than 6% in premarket trading Wednesday.
Lilly plans to apply for Food and Drug Administration approval of donanemab as soon as this quarter, according to the company. The trial studied individuals in the early stages of Alzheimer’s who had a confirmed presence of brain plaque associated with the disease.
Dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer, said donanemab demonstrated the highest level of efficacy of any Alzheimer’s treatment in a clinical trial. The company is working to get donanemab approved and on the market as quickly as possible, he said.
And Skovronsky believes the FDA feels the same sense of urgency.
“Every day that goes by, there are some patients who pass through this early stage of Alzheimer’s disease and become more advanced and they won’t benefit from treatment,” he said in an interview with CNBC. “That’s a very pressing sense of urgency.”
Lilly previously applied for expedited approval of donanemab.
The FDA rejected that request in January and asked the company for more data on patients who received the antibody for at least 12 months. Lilly said the data wasn’t available at the time because many patients were able to stop dosing at six months because the treatment cleared plaque quickly.
Nearly half of patients — 47% — who received donanemab showed no disease progression a year after treatment began, compared with 29% who did not receive the antibody, according to the data released Wednesday.
More than half of patients completed the treatment in the first year and 72% completed it in 18 months due to clearance of brain plaque.
In a separate measure, patients who received donanemab showed 40% less decline in their ability to conduct daily activities at 18 months. This means they could better manage finances, drive, pursue hobbies and hold conversations than those who did not receive the treatment.
“These are the strongest phase 3 data for an Alzheimer’s treatment to date. This further underscores the inflection point we are at for the Alzheimer’s field,” said Maria Carrillo, the Alzheimer’s Association chief scientific officer, in a statement.
Donanemab targets brain plaque associated with Alzheimer’s disease. The treatment significantly reduced the plaque as early as six months after treatment, according to Lilly. Many patients saw such significant reductions that they tested negative for plaque presence on their PET scans, according to the company.
Donanemab cleared the plaque at six months in 34% of patients who had intermediate levels of a protein called tau that can become toxic and kill neurons. At 12 months, donanemab cleared the plaque in 71% of patients with the same tau levels.
“It should be unequivocal that drugs that remove plaque, particularly if you can remove plaque completely and do it quickly, can lead to very significant clinical benefits for patients,” Skovronsky said in an interview.
“The earlier in the disease course you do this, the more you can slow the disease,” he said.
Dr. Eric Reiman, executive director of the Banner Alzheimer’s Institute, said the results do not necessarily mean the plaque is completely gone, but donanemab cleared the plaque to such a degree that the treatment removed measurable evidence of it. The Banner Alzheimer’s Institute had two physicians who participated in the donanemab trial as principal investigators.
Donanemab can cause brain swelling and bleeding in patients that in some cases can be severe and even fatal. Three trial participants died from these side effects, according to Lilly.
These types of side effects have been observed in other Alzheimer antibody treatments such as Eisai and Biogen’s Leqembi, which received expedited FDA approval in January.
Reiman said he’s encouraged by the potential clinical benefit to patients but it’s important to be clear about the risks.
“We also need to be clear that there are side effects, including an uncommon but potentially catastrophic risk,” said Reiman. “And we need to continue to do our best to understand what that risk is for individual patients, to inform patients and family caregivers, and do everything we can to mitigate that risk,” he said.
About 24% of patients who received donanemab showed brain swelling on an MRI, but only 6% displayed actual symptoms. About 31% of patients had small brain bleeds called microhemorrhages, compared with 13.6% among patients who didn’t receive the treatment.
Lilly said the majority of the cases of brain swelling and bleeding were mild to moderate and patients stabilized with the right care, but cautioned that serious and life-threatening events can occur. About 1.6% of the swelling and bleeding cases were serious, according to Lilly.
Skovronsky said every patient would need to have a discussion with their doctor that weighs the potential benefits of donanemab with the possible risks.
“On a population basis, our view is its benefits outweigh risks,” Skovronsky said.
“FDA is the steward of that for the U.S.,” he said of the risk-benefit analysis that will determine whether donanemab wins approval.
Travelers wearing protective masks receive nasal swabs from nurses at a COVID-19 test site inside Terminal B at Los Angeles International Airport (LAX), on Sunday, Nov. 22, 2020.
Bing Guan | Bloomberg | Getty Images
The Biden administration will end its Covid-19 vaccine mandates for federal employees, contractors and international air travelers next week.
The White House said in a statement Monday that those vaccine requirements will end on May 11, the same day the Covid public health emergency expires.
“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” the White House said.
Although Covid cases, hospitalizations and deaths have declined dramatically this year, the virus is still killing more than 1,000 people per week.
The Health and Human Services Department also will start phasing out its vaccine mandate for health-care facilities that participate in Medicare and Medicaid, the White House said. In addition, it will end vaccination requirements for Head Start programs.
And the Department of Homeland Security will lift vaccination requirements for people entering the U.S via its land borders with Canada and Mexico, according to the Biden administration. U.S. citizens, nationals and permanent residents were never subject to those requirements.
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HHS and DHS will provide more details on the end of these vaccine requirements in the coming days, the White House said.
The Biden administration implemented the vaccine requirements for health workers, federal employees, contractors, and international air travelers as part of its drive to boost lackluster vaccination rates and slow the spread of the virus as the delta variant surged in late 2021 followed by omicron in the winter of 2022.
The mandates faced fierce opposition and lawsuits from critics who decried the requirements as government overreach, while the White House stressed they were essential to protect public health.
Seniors with early Alzheimer’s disease will face major hurdles to get treated even if promising new drugs roll out more broadly in the coming years, putting them at risk of developing more severe disease as they wait months or perhaps years for a diagnosis.
The U.S. health-care system is not currently prepared to meet the needs of an aging population in which a growing number of people will need to undergo evaluation forAlzheimer’s, according to neurologists, health policy experts and the companies developing the drugs.
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There are not enough dementia specialists or the needed testing capacity in the U.S. to diagnose everyone who may benefit from a new treatment like Eisai and Biogen‘s Leqembi. After patients are diagnosed, the capacity may not exist — at least initially — to provide the twice monthly intravenous infusions for everyone who is eligible.
Researchers estimate that the wait time from the initial evaluation to the confirmatory diagnostic tests to the infusions could range anywhere from a year and a half to four years or longer. Those months are critical for people with Alzheimer’s.
“The whole process from that time of the family physician conversation to the point of infusion, I worry how long it will take and the complexities of the patient navigating through all of that to successfully get to the end,” Anne White, president of neuroscience at Eli Lilly, which is developing its own Alzheimer’s treatment, told CNBC.
There are promising innovations in development, such as blood tests and injections that patients would take at home, which could make it significantly easier to get diagnosed and treated in the future.
White also said Lilly is confident that more doctors will get into the field and help to alleviate capacity issues, as awareness grows that medicines are entering the market to treat Alzheimer’s.
But time spent waiting robs early patients of their memory and ability to live independently. Alzheimer’s gets worse with time, and as patients deteriorate into more advanced stages of the disease, they no longer benefit from treatments like Leqembi that are designed to slow cognitive decline early.
More than 2,000 seniors transition from mild to moderate dementia from the disease a day, according to estimates from the Alzheimer’s Association. At that stage, they become ineligible for Leqembi.
The central challenge is that a large and rapidly growing group of people have early memory loss and other thinking problems known as mild cognitive impairment. This condition is often, though not always, a sign of early Alzheimer’s disease.
An estimated 13 million people in the U.S. had mild cognitive impairment last year, according to a study published in the Alzheimer’s and Dementia Journal. As the U.S. population ages, the number of people with this condition is expected to reach 21 million by 2060, the study projected.
The U.S. health-care system will deal with major logistical challenges in diagnosing the growing population of people with early Alzheimer’s — even before patients face potential issues with accessing treatment.
“There’s a very large population of undiagnosed cognitive impairments that need to be evaluated in order to determine if people are eligible for treatment,” said Jodi Liu, an expert on health policy at the Rand Corporation.
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Access to drugs like Leqembi is severely restricted because Medicare for nowwill only cover the $26,500-per-year treatment for people participating in clinical trials. Medicare has promised to provide broader coverage if Leqembi receives full approval from the Food and Drug Administration, which Eisai expects to happen in July.
Eisai has estimated that 100,000 people in the U.S. will be diagnosed and eligible for Leqembi by the third year of the treatment’s rollout. The sum is a fraction of the total population that could benefit.
Those patients could have other options if new treatments emerge from trials with positive marks.
Eli Lilly will publish clinical trial data on its antibody infusion donanemab in the second quarter of this year. If the data is positive, the company will ask the FDA to approve the drug.
Eisai’s U.S. CEO Ivan Cheung and Lilly’s White said during the companies’ respective earnings calls in February that they are focused on working with the U.S. health system to address the challenges of rolling out of Alzheimer’s treatments.
“The primary goal right now during this launch phase […] is really get the market ready in terms of the diagnostic pathway, the infusion capacity, the education on how to monitor for this therapy, get all the hospitals and clinics ready,” Cheung said.
Long lines are expected at the offices of geriatricians, neurologists and radiologists as millions of people with mild cognitive impairment undergo evaluation to diagnose whether they have Alzheimer’s disease.
Demand for geriatricians — doctors who are experts in diseases that affect the elderly — is expected to outstrip the number of specialists available in the field through at least 2035, according to projections from the federal Health Resources and Services Administration.
The American Academy of Neurology told Medicare in a February letter that increased demand for Alzheimer’s treatments will put substantial pressure on neurologists, who will need additional resources. The federal data predicts a substantial shortage of these specialists in rural areas through at least 2035.
“You just look at the neurologists, look at geriatricians — there are fewer and fewer geriatricians per person in the U.S.,” Rand’s Liu said. “It’s just a few number of specialists to do this kind of work.”
White said Lilly has heard stories of patients waiting six to 12 months to see a neurologist or other doctors who treat dementia due to current capacity issues.
The number of radiologists — who also play a role in diagnosing the disease — is expected to decline in the U.S. through 2035 even as demand increases, the data shows.
In a study published in 2017, Liu and other Rand researchers estimated an initial wait of 18 months for patients to get evaluated by a dementia specialist, tested to confirm a diagnosis, and then treated in the first year that an Alzheimer’s antibody treatment becomes available. The wait would decrease to 1.3 months by 2030 as the patient backlog is cleared, they estimated at the time.
But more recent research found that the wait would actually increase as demand created by an aging U.S. population outstrips the supply of specialists.
Patients seeking a first specialist visit could face an initial wait of 20 months, according to a study by researchers at the University of Southern California published in the journal Alzheimer’s and Dementia in 2021. The delay could increase to about four years as early as 2028 and grow longer through 2050, the study found.
The journal is published by the Alzheimer’s Association.
Both studies are based on assumptions made before Leqembi received expedited approval from the FDA in January. Actual wait times could differ from the studies’ projections.
Two types of tests can diagnosis Alzheimer’s disease: PET scans and spinal taps. PET scans are accurate and safe diagnostic tools, but they are also cumbersome and expensive, said Dr. David Russell, a neurologist.
Patients are injected with a tracer that makes brain abnormalities visible to the machine that does the imaging. Tracers have to be made for each patient and used on the same day.
“We don’t have the infrastructure to roll out PET scanning on a major scale,” said Russell, director of clinical research at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. He is the principal investigator on the clinical trials of Leqembi and donanemab at the institute.
Medicare coverage of PET scans for Alzheimer’s patients is also limited right now. The insurance program for seniors will only cover one scan per lifetime, and only when the patient is participating in a clinical trail approved by the federal Centers for for Medicare and Medicaid Services.
“That’s concerning because people may actually test negative at one point but then obviously as they age, they may need to get tested again,” White said.
Early Alzheimer’s disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. While there’s plenty of capacity to do spinal taps, this option isn’t attractive to many patients due to unfounded fears that it’s painful and dangerous, Russell said.
Though “there’s a lot of resistance” to the procedure, it is well tolerated and safe, he noted.
“There are certainly areas that don’t have a PET scanner, rural areas, so people would need to travel to a health center that has a PET scanner,” Liu said.
In a large, sparsely populated rural state like New Mexico, many patients would have to drive three to five hours to get a PET scan in a city such as Albuquerque, said Dr. Gary Rosenberg, a neurologist and director of the New Mexico Alzheimer’s Disease Research Center.
“It’s not California or the East Coast where everything’s very compressed and people can travel and get to a center pretty easily and go through these kinds of treatments,” Rosenberg said.
The state has an estimated population of 43,000 people with dementia, and there are very few neurologists outside of the Albuquerque area, Rosenberg said. The New Mexico Alzheimer’s Disease Research Center in Albuquerque is one of only three such facilities funded by the federal National Institute of Aging in a vast region stretching west from Texas to Arizona.
To do a PET scan, a tracer has to be made for each patient off-site in Phoenix, flown on a private plane to Albuquerque and used within hours because the tracers have a short shelf life, according to Rosenberg. The whole process costs more than $12,000 per patient, he added.
“It’s logistically going to be very challenging,” Rosenberg said.
After spending months or possibly years waiting to get diagnosed with early Alzheimer’s, patients would then be eligible for intravenous infusions of Leqembi. But the U.S. doesn’t currently have the capacity to give infusions twice monthly for everyone who likely has the disease, Russell said.
“Having an IV infusion every two weeks would sort of ration people to availability and that’s a problem,” Russell said.
The University of New Mexico Hospital is already maxed out with demand for infusion therapies for cancer, rheumatoid arthritis and autoimmune diseases, and could have a “problem” adding new capacity, said Rosenberg.
Intravenous infusions of monoclonal antibodies like Leqembi aren’t difficult to administer, Russell said.
The infrastructure to offer infusions should expand rapidly once industry sees there’s demand for treatments like Leqembi. But the process of building out capacity could still take a couple years, Russell said. He believes big players like CVS will provide infusions for Alzheimer’s disease on a major scale if they see there’s a large and stable market.
“In one sense, capitalism works, and if it looks like that’s going to be the future, I think infusion centers will explode onto the scene,” the neurologist said.
Eisai and Biogen hope to move early Alzheimer’s patients to a single monthly dose of Leqembi after they’ve completed their initial course of twice monthly infusions, which could help alleviate some of the capacity issues with infusions over time. They plan to ask the FDA to approve this plan in early 2024.
Eli Lilly’s Alzheimer’s candidate antibody treatment donanemab is a single monthly dose, potentially making the logistics of administration easier if the drug gets approved. Dr. Dan Skovronsky, Lilly’s chief medical officer, told analysts during the company’s first-quarter earnings call that he expects many patients will be able to stop taking donanemab at 12 months.
Though the projected wait times to get diagnosed and treated are sobering, innovations on the horizon promise to significantly improve access to Alzheimer’s drugs over time.
Blood tests for Alzheimer’s are in development and some are already on the market. Primary-care doctors could administer the tests, which would ease the burden on patients, especially those in rural communities where the closest PET scan machine is hours away.
These tests detect proteins in the blood associated with Alzheimer’s. They promise to help diagnose the disease before people display cognitive symptoms, potentially giving patients the chance to get treated before they suffer irreparable brain damage, according to the National Institutes of Health.
At least three blood tests made by C2N Diagnostics, Quest Diagnostics and Qaunterix are currently on the market. But they are used to evaluate people who are already presenting symptoms and aren’t available on the mass scale needed for the expected increase in Alzheimer’s patients.
C2N’s PrecivityAD test costs $1,250 and is not covered by insurance — though the company has a financial assistance program. Quest Diagnostics’ AD-Detect test costs $650. Quest’s test is covered by some insurance plans but not Medicare at the moment. The company also has a financial assistance program. Quanterix wouldn’t disclose the price of its test, which insurance does not cover.
Right now, these are not stand-alone tests that can definitively diagnose Alzheimer’s. But the tests could help identify the patients who likely have the disease, which would narrow the population that needs further evaluation and reduce wait times for dementia specialists or confirmatory PET scans.
A study in the journal Alzheimer’s and Dementia estimated that a cognitive test combined with a blood test could slash wait times for dementia specialists from 50 months down to 12 months.
Eisai believes that inexpensive blood tests could completely replace PET scans and spinal taps by the fourth year of Leqembi’s rollout. The quicker diagnosiscould increase the number of people eligible for treatment.
Rosenberg said widespread availability of blood tests will allow mobile clinics to go into rural communities and identify who has markers associated with Alzheimer’s. This would allow patients in remote towns avoid the hours-long drive to cities with PET scan machines, Rosenberg said.
“It’s a game changer,” the neurologist said.
Lilly is developing at least two blood tests. The company is already using one test in clinical trials and hopes to commercialize it sometime this year. It is developing a second test through a collaboration with Roche. White said it is reasonable to expect that in a few years blood tests could replace more burdensome PET scans.
Biogen and Eisai are also developing an injectable form of Leqembi which patients could administer themselves with an autoinjector similar to insulin pens, saving the trip to a site that provides intravenous infusions. They plan to ask the FDA to approve these so-called subcutaneous injections in early 2024.
Eli Lilly is also conducting clinical trials on an antibody treatment called remternetug as a self-administered injection. But the promise of injections that can be administered at home could make companies reluctant to invest in building out intravenous infusion capacity, Russell said.
In the future, Alzheimer’s diagnosis and treatment could be folded into routine checkups with a family doctor, Russell said. When people turn 50 and head in to get a colonoscopy or a cholesterol check, the doctor could also run a blood test for Alzheimer’s.
If the test comes back positive, the doctor could then schedule patients for an MRI and get them started on an autoinjector treatment, Russell said.
“That’s going to be the way that we’re looking at it in the not too distant future,” he said.
Carl Icahn speaking at Delivering Alpha in New York on Sept. 13, 2016.
David A. Grogan | CNBC
Carl Icahn on Friday called Illumina’s first-quarter results “very disappointing” and slammed the DNA sequencing company’s new plans to cut costs.
The activist investor, who owns a 1.4% stake in Illumina, is in a heated proxy fight with the company over its 2021 acquisition of cancer test developer Grail.
Icahn and Illumina have been trading jabs for more than a month.
Icahn is seeking seats on Illumina’s board of directors and pushing the company to unwind the Grail acquisition. He is also calling for the San Diego-based company to oust CEO Francis deSouza “immediately.”
Illumina on Tuesday reported quarterly revenue and earnings that topped Wall Street’s expectations.
But the company also posted net income of $3 million for the quarter, which was down more than 96% from the $86 million it raked in during the same period a year ago.
In an open letter Friday to Illumina shareholders, Icahn accused deSouza of “desperately, hilariously and, most of all, unsuccessfully” trying to spin the “decidedly mediocre” quarterly results during a press tour this week.
Icahn pointed to deSouza’s interview on CNBC’s “Squawk Box” on Wednesday, when the CEO touted strong demand for Illumina’s diagnostic testing services.
“Illumina CEO Francis deSouza seems to believe that he can fool all of the people all of the time,” Icahn wrote.
“Those not skilled in deciphering doublespeak might actually get the impression that Illumina was doing well!” he added.
Icahn also said that the price of Illumina shares fell the more its CEO during this week, “clearly signaling dissatisfaction with the earnings report and dissatisfaction with Mr. deSouza’s transparent attempt to put lipstick on a pig.”
Illumina’s stock is down more than 10% since the company reported earnings. Shares closed largely flat Friday after Icahn released his letter.
In that missive, Icahn also took shots at cost-cutting plans Illumina unveiled to improve its shrinking margins. He called those measures “vague” and “extraordinarily unambitious.”
The company on Tuesday said it will enable unnamed “activities” in more cost-effective areas of the world and will use its new NovaSeq X sequencing system to accelerate genomic discoveries, among other efforts.
Those plans will help Illumina reach its adjusted operating margin goals of 24% in 2024 and 27% in 2025, the company said in its earnings release.
Icahn called those margin targets “less than modest.” And he argued that they will “take years to realize, if they are achieved at all.”
The company has projected an estimated 22% operating margin for 2023, down from the 23.8% it reported in 2022.
Illumina reported a negative operating margin of 5.7% for the quarter, down from 15% during the same period a year ago. The company’s gross margins for the period fell to 60.3%, down from 66.6% in the first quarter of 2022.
Illumina did not immediately respond to a request for comment on Icahn’s letter.
Elsewhere in his letter, Icahn slammed deSouza’s positive remarks this week about Illumina’s $7.1 billion acquisition of Grail.
DeSouza had told CNBC the deal “makes sense” because Illumina can significantly expand the market for Grail’s early screening test for different types of cancer.
The CEO also touted Grail’s 100% revenue growth during the quarter compared with the same period a year ago.
But Icahn said the deSouza failed to tell the public about an opinion issued earlier this month by the Federal Trade Commission, which said that the deal would stifle competition and innovation.
The FTC also ordered Illumina to divest itself of the acquisition over those concerns.
The European Commission, the executive body of the European Union, also blocked the deal last year over similar concerns.
Illumina is appealing both orders and expects final decisions in late 2023 or early 2024.
Last week, a U.S. federal appeals court said that it will fast-track its review of Illumina’s challenge of the FTC order.
Icahn’s resistance to the acquisition stems from Illumina’s decision to close the deal without getting approval from those antitrust regulators.
Earlier this month he strongly criticized Illumina and its management for finalizing the “reckless deal,” calling it “a new low in corporate governance.”
Illumina has urged shareholders to reject Icahn’s three board nominees during its annual shareholder meeting scheduled for May 25.
Demonstrators rally in support of abortion rights at the US Supreme Court in Washington, DC, April 15, 2023.
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The Supreme Court on Friday ordered the abortion pill mifepristone to remain broadly available as litigation plays out in a lower court.
The high court’s decision came in response to an emergency request by the Department of Justice to block lower court rulings that would severely limit access to the medication even in some states where abortion remains legal.
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The case will now be heard in the U.S. 5th Circuit Court of Appeals. The appeals court has scheduled oral arguments for Wed., May 17 at 1 p.m. CT.
Mifepristone has become the flashpoint in the legal battle over abortion since the Supreme Court last summer overturned Roe v. Wade, the landmark 1973 decision that guaranteed abortion nationwide as a constitutional right.
Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions.
President Joe Biden said the court’s decision keeps mifepristone available to women and FDA approved to terminate early pregnancies. Biden said his administration will fight to protect access to mifepristone in the ongoing legal battle in the 5th Circuit Court of Appeals.
“I continue to stand by [the Food and Drug Administration’s] evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” the president said.
Planned Parenthood President Alexis McGill Johnson said the reproductive health-care provider is relieved by the Supreme Court’s decision.
But McGill Johnson warned that access to mifepristone remains in jeopardy as the legal battle plays out in the appeals court.
“While mifepristone’s approval remains intact and it stays on the market for now, patients and health care providers shouldn’t be at the mercy of the court system,” McGill Johnson said. “Medication abortion is very much still under threat — as is abortion and access to other sexual and reproductive health care.”
Justices Samuel Alito and Clarence Thomas, both conservatives, opposed the court’s majority decision to grant the emergency request from the DOJ and Danco Laboratories, the distributor of the brand-name version of the drug, Mifeprex.
The DOJ and Danco, in their emergency requests, told the Supreme Court the restrictions imposed by the lower courts would effectively take mifepristone off the market for months as the FDA adjusted the medication’s labelling to comply with the orders. This would deny women access to an FDA-approved drug that is a safe alternative to surgical abortions, they argued.
Alito rejected that argument in his dissent. The justice said the FDA could simply use its enforcement discretion as the litigation played out and allow Danco to continue distributing mifepristone.
The court’s majority decision to maintain the status quo means mifepristone remains available by mail delivery, and women can obtain the prescription medicationwithout having to visit a doctor in person.
However, in the dozen states that have effectively banned abortion over the past year, the drug will remain largely unavailable. Other states also have restrictions in place that are much tighter than FDA regulations.
The national legal battle over mifepristone began with a lawsuit filed by a coalition of doctors who oppose abortion, the Alliance for Hippocratic Medicine. Those doctors sought to force the FDA to pull the medication from the U.S. entirely.
Earlier this month, U.S. District Judge Matthew Kacsmaryk ruled in favor of the antiabortion doctors and issued a sweeping order that would have halted sales of mifepristone nationwide.
Days later, the U.S. Fifth Circuit Court of Appeals blocked part of Kacsmaryk’s order and allowed Mifeprex to remain on the market. But the appeals court judges imposed restrictions on the medication that would severely limit access.
The appeals court blocked mail delivery of the drug, imposed doctors’ visits as a condition to get the medication, and reduced the length of time when women can take the pill to the seventh week of pregnancy.
The appeals court judges also suspended the 2019 approval of the generic version of mifepristone. The company that sells the generic version, GenBioPro, told the high court the majority of the nation’s supply of the medication would “disappear overnight” if the appeals court ruling went into effect.
GenBioPro said it supplies two-thirds of the mifepristone used in abortions in the U.S.
Johnson & Johnson reported adjusted earnings and revenue that topped Wall Street’s expectations on Tuesday, and lifted its full-year forecast.
J&J, whose financial results are considered a bellwether for many health companies, said its first-quarter sales grew 5.6% over the same quarter last year.
The consumer staples giant reported a net loss of $68 million, or 3 cents per share, due to a special one-time charge. That’s compared to a net income of $5.2 billion, or $1.93 per share, for the same period a year ago. Excluding certain items, adjusted earnings per share were $2.68for the period.
Here’s how J&J results compared with Wall Street expectations based on a survey of analysts by Refinitiv:
Earnings per share: $2.68 adjusted, vs. $2.50 expected
Revenue: $24.75 billion, vs. $23.67 billion expected
J&J is now forecasting 2023 sales of $97.9 billion to $98.9 billion, about $1 billion higher than the guidance provided in January. The company raised its full-year adjusted earnings outlook to $10.60 to $10.70 per share, from a previous forecast of $10.45 to $10.65.
CFO Joseph Wolk told CNBC on Tuesday that J&J raised its guidance due to strong growth across all three business sectors — consumer health, pharmaceuticals and medtech.
“If you think about how we started the year and guidance in January, we were responsibly cautious,” he said on “Squawk Box.” “First-quarter growth was much stronger than even fourth-quarter growth for all three business units, and our positions kind of change to responsibly optimistic at this point. We feel very good about 2023.”
The company’s shares rose nearly 2% in premarket trading. The stock is down more than 6% for the year through Monday’s close, putting the company’s market value at roughly $430 billion.
But the New Brunswick, New Jersey-based company entered this earnings season with its shares on the rise after it offered more clarity on the long-running legal fight over its talc-based baby powder products. Earlier this month, J&J proposed to pay nearly $9 billion over the next 25 years to settle thousands of allegations that its baby powder and other talc products caused cancer.
Moderna’s sign is seen outside of their headquarters in Cambridge, MA on March 11, 2021.
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An experimental mRNA vaccine developed by Moderna combined with Merck’s blockbuster immunotherapy Keytruda cut the risk of death or recurrence of the most deadly skin cancer by 44% compared Keytruda alone, U.S. researchers reported at a medical meeting on Sunday.
The findings suggest that adding a personalized cancer vaccine based on mRNA technology to Keytruda, which revs up the immune response, could prolong the time patients have without recurrence or death, said Dr. Jeffrey Weber of the NYU Langone Perlmutter Cancer Center, who presented the findings.
“From a general cancer therapeutic standpoint, this is a potential major breakthrough,” Dr. Ryan Sullivan, a melanoma expert at Mass General Cancer who worked on the study, said in a statement.
The results, presented at American Association for Cancer Research meeting in Orlando, Florida, add data details to partial findings released by the companies in December.
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech and Gritstone Bio are working on competing cancer vaccines based on mRNA technology.
Moderna’s vaccine is custom-built based on an analysis of a patient’s tumors after surgical removal. The vaccines are designed to train the immune system to recognize and attack specific mutations in cancer cells.
Merck’s Keytruda, which is approved to treat melanoma and many other cancers, belongs to a class of widely used immunotherapies known as checkpoint inhibitors designed to disable the PD-1, or programmed death 1, protein that helps cancer evade the immune system.
The midstage trial enrolled men and women at high risk of their melanoma returning.
Among 107 study subjects who received both the experimental vaccine, mRNA-4157/V940, and Keytruda, cancer returned in 24 subjects (22.4%) within two years of follow-up, compared with 20 out of 50 (40%) who received Keytruda alone.
There was little difference in response rates among people whose tumors had a lot of mutations – a typical predictor of immunotherapy response – and those whose tumors did not.
Severe side effects were similar between the two arms of the study, the scientists reported. Fatigue was the most common side effect reported by patients specifically associated with the vaccine.
Merck said the companies are in talks with U.S. regulators about the design of a late-stage trial, which is likely needed for approval of the combination regimen.
It could take three or four years before the results of the larger trials are known, Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.
Barr said it took Moderna about eight weeks to design a personalized mRNA vaccine for each patient.
In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen.
Moderna’s mRNA technology allowed for the inclusion of as many as 34 neoantigens, which Barr called “astonishing.”
Currently, scientists cannot predict which single mutation is important in generating an anti-tumor response. With mRNA technology in combination with Keytruda, “we can create this shotgun approach … that can create a more potent immune response,” Barr said.
Pills of Misoprostol, used to terminate early pregnancies, are displayed in a pharmacy in Provo, Utah, May 12, 2022.
George Frey | Reuters
New York and California are stockpiling massive quantities of an alternative abortion medication in case a federal judge’s order suspending the Food and Drug Administration’s approval of the main drug mifepristone goes into effect later this week.
New York Gov. Kathy Hochul on Tuesday ordered the state health department to immediately start purchasing 150,000 doses of misoprostol, a five-year supply of the pill. Hochul’s announcement comes a day after Gov. Gavin Newsom said California has secured 2 million pills of misoprostol.
Medication abortions are the most common way to terminate a pregnancy the U.S. Patients typically use a two drug-regimen in which mifepristone is taken first, followed by misoprostol. The second pill is used as a standalone abortion medication in parts of the world.
Misoprostol is FDA approved to treat gastric ulcers, so it will remain on the market if U.S. District Judge Matthew Kacsmaryk’s order suspending mifepristone takes effect at 12 a.m. central time on Saturday.
“One judge in Amarillo, Texas thinks he knows better than thousands of doctors and scientists and experts. And not to mention the countless women who’ve used this medication safely for decades,” Hochul said during a press conference with Planned Parenthood’s New York chapter Tuesday.
“This isn’t just an attack on abortion, it’s an attack on democracy. Courts have never before revoked a science backed decision made by the FDA,” the governor said.
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Hochul said she is working with New York’s legislature to require private insurers to cover misoprostol when it is prescribed off-label for abortions.
The World Health Organization and the American College of Obstetricians and Gynecologists recommend misoprostol as a standalone abortion medication when the two-drug regimen is not available. But misoprostol is not as effective when it is used on its own, according to obstetricians and gynecologists.
The FDA has approved the two-drug abortion regimen through the 10th week of pregnancy. Mifepristone stops the pregnancy from developing further by blocking a hormone called progesterone. Misoprostol induces contractions that empty the uterus.
Patients take 200 milligrams of mifepristone by mouth on day one, and then take 800 micrograms of misoprostol in the cheek pouch 24 to 48 hours later, according to the FDA’s label.
Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, on March 15, 2023.
Moises Avila | AFP | Getty Images
A federal judge in Texas on Friday suspended the Food and Drug Administration’s approval of the abortion pill mifepristone nationwide, but delayed the ruling from taking effect for a week to give the Biden administration time to appeal.
But minutes after the Texas decision was announced, a federal judge in Washington state issued a preliminary injunction that said essentially the opposite.
The seemingly conflicting federal court rulings out of Texas and Washington state means the Supreme Court may ultimately weigh in on the legality of mifepristone in the U.S., which was approved by the FDA more than two decades ago in 2000.
Used in combination with another drug called misoprostol, mifepristone is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions.
U.S. Judge Matthew Kacsmaryk of the U.S. Northern District of Texas held a key hearing in the case weeks ago in Amarillo, but the news of the decision that could upend access to the key abortion drug only came down late on a Friday when many Americans were off for religious observances.
Kacsmaryk endorsed nearly all of the plaintiffs’ arguments about their right to sue, which called for the removal of the FDA’s approval of the drug. He argued mifepristone has serious safety issues, sidelining the FDA’s long-standing determination that the drug is safe and effective.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
But in a dramatic turn, Judge Thomas Owen Rice of the U.S. District for the Eastern District of Washington essentially countered the Texas decision, when he barred the FDA from “altering the status quo and rights as it relates to the availability of mifepristone” in the 17 states and D.C. that sued to keep pill on the market there.
Boxes of the medication Mifepristone used to induce a medical abortion are prepared for patients at Planned Parenthood health center in Birmingham, Alabama, March 14, 2022.
Evelyn Hockstein | Reuters
U.S. Attorney General Merrick Garland said Kacsmaryk’s ruling in Texas “overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective.” Garland said the Justice Department will appeal the Texas ruling and defend the FDA approval.
The case will go to the U.S. 5th Circuit Court of Appeals. If the Biden administration fails to convince that court to overturn Kacsmaryk’s ruling, access to mifepristone would be in jeopardy across the U.S.
But the ruling out of Washington state may protect access at least in Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington state and D.C.
Kacsmaryk’s decision will not affect access to misoprostol, which is commonly used as a standalone abortion drug in other parts of the world. Some abortion providers have said they plan to use misoprostol as an alternative to the two-drug regimen if mifepristone is pulled from the market.
A coalition of physicians opposed to abortion, called the Alliance for Hippocratic Medicine, sued the FDA in November over its approval of mifepristone. The group argued that the FDA abused its authority by approving mifepristone through an accelerated process for new drugs that help patients with serious or life-threatening illnesses more than what is otherwise available on the market.
Kacsmaryk embraced the group’s claims Friday, arguing that pregnancy is not an illness and mifepristone does not provide a meaningful therapeutic benefit over surgical abortion.
The anti-abortion physicians were represented by attorneys from the Alliance Defending Freedom, an organization that worked with Mississippi lawmakers to draft the law at the center of Dobbs v. Jackson Women’s Health Organization. That case ultimately resulted in the Supreme Court overturning Roe v. Wade.
Kacsmaryk joined the court in 2019 after his appointment by former President Donald Trump. Kacsmaryk’s nomination was unanimously opposed by Senate Democrats as well as Republican Susan Collins of Maine, who supports abortion rights.
His nomination was also opposed by abortion and LGBTQ rights organizations such as Planned Parenthood and the Human Rights Campaign.
The FDA called the case “extraordinary and unprecedented” in its January response to the lawsuit. The agency’s lawyers said they could not find any previous example of a court second-guessing an FDA decision to approve a drug.
The agency also said mifepristone was not approved under an accelerated pathway. It took more than four years from the filing of the initial application until the pill was approved.
The FDA approved mifepristone as a safe and effective method to terminate an early pregnancy based on extensive scientific evidence, the agency’s lawyers wrote. Decades of experience among thousands of women have confirmed that the drug regimen is the safest option for many patients compared with surgical abortion or childbirth, the lawyers argued.
The FDA warned that pulling mifepristone from the U.S. market would put the health of women at risk if they cannot get access to the pill to safely end pregnancies. It would also weaken the FDA’s federal drug approval powers and hinder drug development by creating regulatory uncertainty in the marketplace, the government’s lawyers have said.
“If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the Biden administration lawyers wrote.
Mifepristone has been subject to FDA restrictions since its approval in 2000 to monitor the pill’s safety and efficacy. These restrictions have been subject to criticism and litigation from medical associations such as the American College of Obstetricians and Gynecologists and more recently from attorneys general in Democratic- led states.
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The FDA has gradually eased the restrictions on mifepristone over the years as more evidence has come in. The agency dropped previous rules that required in-person visits with medical professionals, allowing the pill’s delivery by mail. The FDA recently allowed certified retail pharmacies to dispense mifepristone when the patient has a prescription from a health-care provider that’s approved under the agency’s monitoring program.
Misoprostol, the drug that’s used with mifepristone, is recommended as a stand-alone method to terminate a pregnancy by the World Health Organization. But the FDA has not approved misoprostol as an abortion medication on its own.
The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative for early abortions if mifepristone is not available, though it’s not as effective as the two-drug regimen, according to the organization.
Here’s an update on the health care and financial holdings in Jim Cramer’s Charitable Trust, the portfolio we use at the CNBC Investing Club. Jim ran through all 35 of the stocks during the Club’s inaugural Annual Meeting on Saturday, an in-person event held in New York City. A video replay of the meeting is available here . Bausch Health (BHC): Shares of the troubled pharmaceutical company have gotten off to a solid start in 2023. However, the fundamental problems that led us to assign Bausch Health our only wait-and-see 4 rating remain a concern. Legal uncertainties around the patent for its key drug, Xifaxan, in addition to BHC’s debt load, continue to be main overhangs on the stock. Those are reasons why it’s off-limits for us until we get more information. At the same time, we’d be remiss not to mention some of the reasons for the stock’s early 2023 rally, including Brent Saunders’ appointment as CEO of Bausch + Lomb (BLCO), the eye-care firm Bausch Health spun out last year. BHC still owns nearly 90% of Bausch + Lomb, with plans to further monetize that stake and use the proceeds to pay down debt. In that sense, good news at BLCO also is good news for BHC. Danaher (DHR): Danaher might be the best-run industrial company in the country. Guided by the Danaher Business System, management has a strong track record of acquiring firms and then improving their margins once they’re under the same corporate roof. We’re bullish on the life sciences and medical diagnostics company’s plans to soon separate its Environmental & Applied Solutions division into its own firm. Danaher has really leaned into the life sciences industry in recent years. At levels below $250 per share, Jim said Danaher is one of the most attractive stocks in the Club’s portfolio. He also said that in response to a member’s question that Danaher, like Apple (AAPL), is a stock that he prefers to own for the long term, rather than trade in and out of it. Humana (HUM): The health insurer has twice raised its 2023 Medicare Advantage enrollment guidance in recent months, a clear sign that management’s market-share strategy is playing out as expected. The company has really enhanced the benefits of its offering over the past year or so. While a few regulatory questions weighed on Humana and other health-insurance names to start 2023, investors have since gotten clarity on those matters. Plus, Wall Street’s rekindled inflation fears in recent weeks have made defensive-oriented stocks such as Humana seem like more attractive places to be. Humana is expected to grow earnings at a solid clip this year, and we think it still is fairly valued. Johnson & Johnson (JNJ): The health-care firm’s upcoming breakup should be beneficial for both entities upon its completion. Its consumer-products unit will become a company known as Kenvue, while its faster-growing pharmaceutical and medical devices divisions will retain the J & J name. This approach should allow the respective management teams to be more focused and more efficiently allocate capital. However, there is some litigation risk with J & J after a federal judge in January rejected its strategy concerning more than 38,000 talc lawsuits. Management is committed to resolving the cases as effectively and swiftly as possible, and Jim said he believes over the long term that will happen. Against that backdrop, we view J & J as a quality defensive name to own, especially given its annual dividend yield of around 3%. Eli Lilly (LLY): The company looks like the most compelling growth story of any large-cap pharmaceutical player. Its type 2 diabetes drug Mounjaro is being studied to treat a host of other medical conditions, including obesity, where trials have shown impressive weight-loss results. We think it’s poised to become one of the best-selling drugs in history, if not the top seller, and the company is investing in expanding manufacturing capacity to meet what’s expected to be fervent demand, assuming it receives regulatory approval for obesity later this year. Lilly also is expected to release the results of its late-stage Alzheimer’s trial in the coming months. Success in that study is not central to our investment case, but the opportunity is sizable. Morgan Stanley (MS): Morgan Stanley’s fourth-quarter results demonstrated the power of the bank’s revenue diversification strategy. CEO James Gorman’s decision to lean into asset management — and the more stable fee-based earnings stream associated with it — is a key element to our investment thesis. Eventually, we think the market will come to fully recognize that Morgan Stanley is not the same old investment bank of the past and assign its stock a premium valuation. We’re not all the way there yet. But in the meantime, Morgan Stanley’s over 3% annual dividend yield and steady stock buyback program will continue to reward patient shareholders. With a competitive and proven leader like Gorman at the helm, Morgan Stanley is a stock to hold. Wells Fargo (WFC): The money-center bank is one of our largest positions in the portfolio, and its stock has recently been helped by the increase in interest rates engineered by the Fed to fight inflation. The reason higher rates enable Wells Fargo to make more money from its massive pile of customer deposits is an industry metric known as net interest income (NII). Big picture, Wells Fargo continues to be an attractive turnaround story as CEO Charlie Scharf works to overcome a series of past scandals under prior management. There are some remaining regulatory hurdles, most prominently a Fed-mandated asset cap that effectively constrains Wells Fargo’s ability to issue new loans. However, we eventually believe that will be lifted, even if the timeline is uncertain. In the meantime, Wells Fargo restarted its share repurchase program in the current quarter, and management’s disciplined expense outlook should help protect earnings. (Jim Cramer’s Charitable Trust is long BHC, DHR, JNJ, LLY, HUM, MS, WFC. See here for a full list of the stocks.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust’s portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.
The logo of Morgan Stanley is seen in New York
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Here’s an update on the health care and financial holdings in Jim Cramer’s Charitable Trust, the portfolio we use at the CNBC Investing Club. Jim ran through all 35 of the stocks during the Club’s inaugural Annual Meeting on Saturday, an in-person event held in New York City. A video replay of the meetingis available here.
Medicare will not provide broader coverage of the Alzheimer’s drug Leqembi until it receives more evidence that the treatment is reasonable and necessary, according to the federal agency that runs the program for seniors.
The Centers for Medicare and Medicaid Services rejected a request from the Alzheimer’s Association for unrestricted coverage of antibody treatments approved by the Food and Drug Administration that target brain plaque associated with the devastating disease.
“After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration,” CMS said in a statement on Wednesday.
The FDA cleared Leqembi on an expedited basis in January after clinical trial results showed that the treatment slowed cognitive decline by 27% in patients with early Alzheimer’s disease. The drug also carries risks of brain swelling and bleeding.
Leqembi was developed by the Japanese pharmaceutical company Eisai and its partner Biogen. When drugs like Leqembi are approved on expedited basis, Medicare will only cover them for patients who are participating in clinical trials.
“As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary,” the agency said in its statement. “This standard differs from the criteria used by the FDA to assess whether medications are safe and effective.”
Eisai, which completed its phase three trial, has priced Leqembi at $26,500 per year. Due to the drug’s high price and Medicare’s coverage restrictions, seniors are unable to access the treatment.
“CMS’ role is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate. Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary,” said the association’s president Joanne Pike.
The letter the Alzheimer’s Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. The American Academy of Neurology has also told CMS that its experts reviewed Eisai’s clinical trial and concluded that the study was well designed and Leqembi provides a clinical benefit.
The Alzheimer’s Association estimates that 2,000 people ages 65 and older progress from mild dementia to a more advanced stage of the disease per day, which would make them ineligible for Leqembi.
CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Eisai U.S. CEO Ivan Cheung told CNBC last week that the company expects to receive full FDA approval this summer.
But even with full approval, Medicare’s policy is to cover Alzheimer’s treatments for patients who agree to participate in research studies that collect real-world data. While coverage would be broader, such studies need to be set up and health-care providers have to agree to participate. This would likely still limit the number of people who can access the drug.
But Cheung told CNBC that Medicare could agree to even broader coverage, possibly with no restrictions, if CMS determines that there’s a high level of evidence supporting the treatment.
“With a high level of evidence … the restrictions should be very limited, or maybe even no restrictions and that is Eisai’s position,” Cheung said. “We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria.”
Members of Congress, including 20 senators and more than 70 House members, have called on CMS to change its policy and offer broader coverage of Alzheimer’s antibody treatments. People living in rural and underserved communities face a disadvantage because the institutions that host clinical trials are usually in bigger cities.
“Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment,” the House lawmakers told Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure. “It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials.”
Medicare adopted the coverage restrictions after controversy over the Alzheimer’s antibody treatment Aduhelm, which was also developed by Eisai and Biogen. The FDA approved that treatment over the objections of its independent advisors, who said the data did not demonstrate a benefit for patients. Three advisors resigned over the FDA decision, and a congressional investigation found irregularities in the approval process.
Join CNBC’s Healthy Returns on March 29th, where we’ll convene a virtual gathering of CEOs, scientists, investors and innovators in the health care space to reflect on the progress made today to reinvent the future of medicine. Plus, we’ll have an exclusive rundown of the best investment opportunities in biopharma, health-tech and managed care. Learn more and register today: http://bit.ly/3DUNbRo
The Food and Drug Administration’s independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the life-saving treatment.
Emergent BioSolutions‘ Narcan is the most commonly sold treatment for opioid overdoses. The FDA is expected to make a decision by March 29 on whether to allow people to buy the four milligram nasal spray without a prescription. The agency is not required to accept its advisors recommendation, though it typically does so.
Emergent BioSolutions said Narcan would be available for the over-the-counter market by late summer if the FDA approves it next month. The company has not yet disclosed how much it would cost.
“We have been working on distribution plans with key stakeholders like retailers and government leaders,” said Matt Hartwig, a spokesperson for the company.
Most states have already issued blanket prescriptions that allow pharmacies to distribute Narcan, generically known as naloxone, without the patient having to present a script. But FDA approval of Narcan for over-the-counter use would allow more people to acquire the treatment more easily in more places.
“If naloxone becomes a nonprescription product, it may be sold in many venues previously unavailable to consumers, including vending machines, convenience stores, supermarkets and big box stores, just like other nonprescription products,” Jody Green, an official at the FDA’s nonprescription drug division, told the advisory committee Wednesday.
Since 1999, more than 564,000 people have died from opioids in the U.S. in three waves — first from prescription opioids, then from heroin and most recently from fentanyl, according to the Centers for Disease Control and Prevention. Opioid overdose deaths spiked 17% during the pandemic from about 69,000 in 2020 to nearly 81,000 in 2021.
The Trump administration first declared the opioid epidemic a public health emergency in 2017. The Biden administration has renewed the emergency declaration every 90 days since the president took office.
“Each day 187 people will die — this is absolutely tragic as we think of not only the individuals themselves, but the families, the communities, the workplaces. This has profound human impact and we are all impacted from this,” Manish Vyas, senior vice president of regulatory affairs at Narcan maker Emergent BioSolutions, told the committee.
Scott Hadland, head of adolescent medicine at Massachusetts General Hospital, said the widespread infiltration of fentanyl into the nation’s drug supply has increased the risk of overdoses. Many people who are exposed to fentanyl take counterfeit pills that they thought were prescribed but actually contain the highly potent and often deadly opioid, Hadland said.
“And increasingly there are secondhand exposures that are also rising,” Hadland, who participated in Emergent BioSolutions’ presentation, told the committee. “We’re seeing rising overdose deaths among toddlers who are coming across fentanyl in public settings or fentanyl that may be elsewhere in the home.”
Hadland said he tells parents to to keep Narcan at their home in case of an emergency. He compared it to a fire extinguisher that families should have for safety reasons but hopefully will never have to use.
“Unfortunately for most young people, families and community members all across this country, current avenues of access are challenging,” Hadland said.
Dr. Bobby Mukkamala of the American Medical Association said Narcan should be as easy to obtain as Tylenol to treat a headache or a decongestant for a stuffy nose. The life-saving nasal spray should be just as common in public places as AED devices that are used to treat people suffering from heart attacks.
Jessica Hulsey, executive director of the Addiction Policy Forum, told the committee during a public comment section that Narcan needs to be priced affordably at no more than $20 per dose if it’s sold over the counter. Narcan is packaged as single doses and it can take multiple doses to reverse an overdose from highly potent fentanyl.
Narcan displaces opioids that bind to receptor sites in a person’s nervous system. By displacing and blocking opioids, the nasal spray prevents fatal overdoses by reversing respiratory depression, said Gay Owens, head of global medical affairs at Emergent BioSolutions.
But Narcan has to be administered as soon as an overdose is suspected, which is why it’s crucial to make sure the instructions for using the nasal spray are simple, the FDA’s Green said.
In a study sponsored by Emergent BioSolutions, more than 90% of 71 participants understood over-the-counter label directions and used the Narcan device correctly during a simulated overdose emergency using mannequins. The participants included people with varying levels of literacy, and both adults and adolescents.
But some participants were confused by the five-step instructions because they were split across the side and back panels of the carton, said said , senior pharmacist at the FDA division that monitors errors in administering medicine. This confusion could result in delayed administration or errors in using the Narcan device correctly when time is of the essence, according to Shah.
These instances occurred despite the fact that the participants were allowed as much time as needed to familiarize themselves with the Narcan instructions, which may not be the case in a real-world overdose emergency, according to Shah.
“Therefore, the data collected does not capture this highest-risk use scenario,” said Shah.
The FDA has proposed that Emergent BioSolutions place all five instructions in sequential order on the back panel of the carton and also include instructions in the device blister pack. The company presented a mockup at the advisory meeting, but the FDA said it has not evaluated it yet.
Vials and a medical syringe seen displayed in front of the Food and Drug Administration (FDA) of the United States logo. FDA finds the COVID-19 vaccine.
Pavlo Gonchar | LightRocket | Getty Images
The Food and Drug Administration on Tuesday said its emergency authorizations of Covid vaccines, tests and treatments will not be impacted by the end of the public health emergency this spring.
President Joe Biden is planning to terminate in May the public health and national emergencies declared in response to the Covid pandemic three years ago, the White House said Monday. The public health emergency gave U.S. health regulators expanded powers to respond faster to the pandemic.
The FDA’s emergency powers, however, aren’t directly tied to public health declaration, according to the agency.
Former Health Secretary Alex Azar made separate determinations in February and March of 2020 under the Food, Drug and Cosmetics Act that the circumstances of the pandemic justified the authorization of vaccines, treatments and tests for emergency use.
The FDA used its emergency powers to authorize the Pfizer, Moderna, Johnson & Johnson and Novavax vaccines. The agency also authorized the oral antivirals Paxlovid and molnupiravir, several antibody treatments as well as numerous tests and other medical devices on an emergency basis.
“Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met,” The FDA wrote in post on Twitter Monday.
Emergency authorizations allow the FDA to roll out medical products before they receive the agency’s full approval. This allows the agency to respond more swiftly to public health crises.
The Centers for Disease Control and Prevention on Friday urged people with weak immune systems to take extra precautions to avoid Covid after the dominant omicron subvariants knocked out a key antibody treatment.
These precautions include wearing a high quality mask and social distancing when it’s not possible to avoid crowded indoor spaces, according to the CDC.
The guidance comes after the Food and Drug Administration on Thursday pulled its authorization of Evusheld, a combination antibody injection that people with weak immune systems took as an additional layer of protection to prevent Covid infection.
The FDA pulled Evusheld because it is not effective against 95% of the omicron subvariants circulating in the U.S. This includes the XBB subvariants which are now causing 64% of new cases, as well as the BQ family that is responsible for 31% of reported infections.
Although most Americans have largely returned to normal life as the Covid pandemic has ebbed, people with weak immune systems remain at higher risk of severe disease because they do not mount as strong of an immune response to the vaccines.
Still, it is important for people with weak immune systems to stay up to date on their Covid vaccines by receiving the omicron booster because the shots can slash the risk of severe disease, according to the CDC.
If you have a weak immune system and develop Covid symptoms, you should get tested as soon as possible and receive treatment with an antiviral within five to seven days, according to CDC.
Available antivirals include Paxlovid, remdesivir or molnupiravir, but patients should talk to their doctor to find out which treatment is best. Some people cannot take Paxlovid due to how it interacts with other drugs they are taking.
People with weak immune systems include cancer patients who are on chemotherapy, organ transplant patients who are taking medication for their transplant, people with advanced HIV infection, and those born with immune deficiencies.
Some 7 million adults in the U.S. have a condition, like cancer, that compromises their immune system, according to the CDC.
A woman shops in the pharmacy area of a Walmart store in Mount Prospect, Illinois.
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Walmart Inc said on Friday it would adjust working hours for its U.S. pharmacy team and implement it nationwide in 4,600 locations, with drugstore operator CVS Health Corp doing the same for about two-thirds of its retail pharmacies, amid a tight labor market.
The United States has been experiencing a nationwide labor shortage since the Covid-19 pandemic which has forced retailers to offer attractive incentives and pay increases.
Walgreens Boots Alliance and CVS each raised their minimum wage to $15 per hour in 2021 while Walmart said last year it would increase the average pay of pharmacy workers to more than $20 per hour.
Earlier on Friday, the Wall Street Journal first reported CVS Health Corp and Walmart were cutting pharmacy hours.
Walmart’s pharmacies will be open from 9 a.m. to 7 p.m., Monday through Friday from March, while the weekend hours would not change, a spokesperson for the company said. Currently, they are open from 9 a.m. to 9 p.m.
CVS said the new hours of operation, which begin in March, at impacted pharmacies will vary, adding it periodically reviews operating hours to make sure peak customer demand was being met.
The company had 9,900 retail locations including pharmacies, according to a regulatory filing in February 2022.
Walgreens said in a statement that at times it had to adjust store or pharmacy hours at some places after staffing challenges impacted retailers and healthcare entities, among others, over the last 12 months.
Martin Shkreli, former chief executive officer of Turing Pharmaceuticals AG, center, pauses while speak to members of the media with his attorney Benjamin Brafman, right, outside federal court in the Brooklyn borough of New York, U.S., on Friday, Aug. 4, 2017.
Peter Foley | Bloomberg | Getty Images
The Federal Trade Commission on Friday asked that notorious “pharma bro” Martin Shkreli be held in contempt of court for forming a new drug company in violation of a judge’s ban on the convicted fraudster from working in the pharmaceuticals industry.
Shkreli, who was released from prison last year, in February was banned “for life from directly or indirectly participating in any manner in the pharmaceutical industry” as a result of the FTC’s antitrust lawsuit against him and a prior drug company that he founded.
That order stemmed from Manhattan federal court Judge Denise Cote’s ruling that Shkreli oversaw an illegal scheme to maintain a monopoly on the life-saving drug Daraprim, which continued even as he sat in prison for his conviction in an unrelated securities fraud case.
In its court filing Friday, the FTC noted that Shkreli in July announced the formation of a new company, Druglike, “that appears to be involved in the drug industry.”
The agency said that action, as well as Shkreli’s failure to pay his nearly $25 million share of a $64.6 million judgment he owes in the lawsuit, suggest that he is violating the court’s orders in the case.
The FTC and a group of states that sued Shkreli said in the filing he has failed to comply with their requests to give them documents and submit to an interview as part of their probe into whether his involvement with Druglink violates the February 2022 court order banning him from the industry.
“Martin Shkreli’s failure to comply with the court’s order demonstrates a clear disregard for the law,” said Holly Vedova, director of the FTC’s Bureau of Competition, in a statement.
“The FTC will not hesitate to deploy the full scope of its authorities to enable a comprehensive investigation into any potential misconduct,” Vedova said.
Benjamin Brafman, a lawyer for Shkreli, did not immediately reply to a request for comment.
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The Centers for Disease Control and Prevention on Friday said it is “very unlikely” the Pfizer omicron booster carries a risk of stroke for seniors after it launched an investigation into a preliminary safety concern detected by one of its monitoring systems.
The CDC, in a statement posted to its website Friday, said a surveillance system called the Vaccine Safety Datalink detected a possible risk for stroke in people ages 65 and older who received the Pfizer booster shot targeting the omicron Covid variant. A CDC spokesperson said this issue was first detected in late November.
By mid-December, the CDC concluded the concern was persisting and launched an investigation into whether seniors are more likely to have a stroke in the first 21 days after receiving the Pfizer booster, the spokesperson said. A similar preliminary signal was not detected for Moderna’s booster.
The VSD monitoring system found that 130 people ages 65 and older had a stroke within 21 days of receiving the Pfizer omicron booster among about 550,000 seniors who received the shot, the CDC spokesperson said. No deaths have been reported. The Washington Post earlier reported the news.
No other surveillance system has detected a similar safety concern for the Pfizer booster so far, according to the CDC. Investigators have not found an increased risk of stroke following the Pfizer booster after reviewing data from the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, the Vaccine Adverse Reporting System and Pfizer’s global safety database.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the CDC said in the post on its website.
The monitoring systems often detect safety signals that are due to factors other than the vaccine, according to the CDC’s Friday statement. The agency spokesperson said investigators hope to have a clearer picture and more data in the coming weeks.
The investigation will be discussed at an upcoming meeting of the Food and Drug Administration’s panel of independent vaccine experts on Jan. 26.
In a statement Friday, Pfizer said there is no evidence to conclude that ischemic stroke is associated with company’s Covid vaccine.Neither Pfizer and its German partner BioNTech, nor the CDC or the FDA, have observed such an association in numerous other monitoring systems in the U.S. and globally, company spokesperson Kit Longley said.
“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the omicron BA.4/BA.5-adapted bivalent vaccine,” Longley said.
The CDC has not changed its recommendation for the Pfizer omicron shot. Everyone ages 5 and older is eligible for the booster after completing their primary vaccine series. The youngest kids ages 6 months through 4 years old receive the omicron shot as the third dose of their primary series.
The Covid Omicron XBB.1.5 variant is rapidly becoming dominant in the U.S. because it is highly immune evasive and appears more effective at binding to cells than related subvariants, scientists say.
XBB.1.5 now represents about 41% of new cases nationwide in the U.S., nearly doubling in prevalence over the past week, according to the data published Friday by the Centers for Disease Control and Prevention. The subvariant more than doubled as a share of cases every week through Dec. 24. In the past week, it nearly doubled from 21.7% prevalence.
Scientists and public health officials have been closely monitoring the XBB subvariant family for months because the strains have many mutations that could render the Covid-19 vaccines, including the omicron boosters, less effective and cause even more breakthrough infections.
XBB was first identified in India in August. It quickly become dominant there, as well as in Singapore. It has since evolved into a family of subvariants including XBB.1 and XBB.1.5.
Andrew Pekosz, a virologist at Johns Hopkins University, said XBB.1.5 is different from its family members because it has an additional mutation that makes it bind to cells better.
“The virus needs needs to bind tightly to cells to be more efficient at getting in and that could help the virus be a little bit more efficient at infecting people,” Pekosz said.
Yunlong Richard Cao, a scientist and assistant professor at Peking University, published data on Twitter Tuesday that indicated XBB.1.5 not only evades protective antibodies as effectively as the XBB.1 variant, which was highly immune evasive, but also is better at binding to cells through a key receptor.
Scientists at Columbia University, in a study published earlier this month in the journal Cell, warned that the rise of subvariants such as XBB could “further compromise the efficacy of current COVID-19 vaccines and result in a surge of breakthrough infections as well as re-infections.”
The XBB subvariants are also resistant to Evusheld, an antibody cocktail that many people with weak immune systems rely on for protection against Covid infection because they don’t mount a strong response to the vaccines.
The scientists described the resistance of the XBB subvariants to antibodies from vaccination and infection as “alarming.” The XBB subvariants were even more effective at dodging protection from the omicron boosters than the BQ subvariants, which are also highly immune evasive, the scientists found.
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Dr. David Ho, an author on the Columbia study, agreed with the other scientists that XBB.1.5 probably has a growth advantage because it binds better to cells than its XBB relatives. Ho also said XBB.1.5 is about as immune evasive as XBB and XBB.1, which were two of the subvariants most resistant to protective antibodies from infection and vaccination so far.
Dr. Anthony Fauci, who is leaving his role as White House chief medical advisor, has previously said that the XBB subvariants reduce the protection the boosters provide against infection “multifold.”
“You could expect some protection, but not the optimal protection,” Fauci told reporters during a White House briefing in November.
Fauci said he was encouraged by the case of Singapore, which had a major surge of infections from XBB but did not see hospitalizations rise at the the same rate. Pekosz said XBB.1.5, in combination with holiday travel, could cause cases to rise in the U.S. But he said the boosters appear to preventing severe disease.
“It does look like the vaccine, the bivalent booster is providing continued protection against hospitalization with these variants,” Pekosz said. “It really emphasizes the need to get a booster particularly into vulnerable populations to provide continued protection from severe disease with these new variants.”
People are seen waiting at the arrivals area of terminal 5 at Heathrow International airport.
Carlos Barria | Reuters
LONDON — The U.K. and France said Thursday morning they currently had no plans to reintroduce mandatory Covid-19 tests or additional requirements for travelers arriving into the country.
Italy, the center of Europe’s initial outbreak in early 2020, on Wednesday became the first country in the region to announce that mandatory antigen swabs would be required of all travelers coming from China.
On one Dec. 26 flight from China into Milan’s Malpensa Airport, 52% of passengers tested positive for Covid, la Repubblica reported.
European Union health officials were locked in talks Thursday to try to coordinate a response.
“From a scientific point of view, there is no reason at this stage to bring back controls at the borders,” Brigitte Autran, head of the French health risk assessment committee COVARS, said on France’s Radio Classique, according to a Reuters report.
German and Austrian officials on Wednesday also appeared reluctant to introduce new restrictions.
But Italy’s National Institute of Infectious Diseases reportedly called for an increase in testing for those arriving from China. “It would be better if the coordination of surveillance should take place at European level,” the institute said, according to a translation by the Ansa news agency.
The U.S. said from Jan. 5. all arrivals from mainland China, Hong Kong and Macau must supply a negative Covid test taken within two days of departure.
India will require a negative test from passengers arriving from China, Japan, South Korea, Hong Kong and Thailand, with passengers put into quarantine if they have a positive test or display Covid symptoms. Japan will perform tests on arrival for passengers from mainland China, Reuters reported.
The U.K. government is expected to monitor the situation through Thursday and could announce a change in policy, especially if a wave of other European countries reintroduce testing.
Officials have cited a lack of published information from China on new variants as a reason to strengthen precautions.
Beijing says its latest outbreak is down to the highly transmissible, but less deadly, omicron variant. But a lack of data and the country’s track record of obfuscating reality has meant that many nations are taking a cautious approach.
The U.S. recorded more than 100 million formally diagnosed and reported Covid-19 cases this week, but the number of Americans who’ve actually had the virus since the beginning of the pandemic is probably more than twice as high.
Covid-19 has easily infected more than 200 million in the U.S. alone since the beginning of the pandemic — some people more than once. The virus continues to evolve into more transmissible variants that dodge immunity from vaccination and prior infection, making transmission incredibly difficult to control as we go into the fourth year of the pandemic.
The U.S. officially recorded more than 100 million cases as of Tuesday, just under one third of the total population, according to data from the Centers for Disease Control and Prevention. The data isn’t perfect and likely a huge undercount of the actual number of infections, scientists say. While it counts people who’ve tested positive more than once or caught Covid multiple times, it doesn’t capture the number of Covid patients who were asymptomatic and never test or tested at home and didn’t report it.
Dr. Tom Frieden, former CDC director under the Obama administration, estimates that the reported data reflects less than half of the actual total.
“There are have been at least 200 million infections in the U.S., so this is a small portion of them,” Frieden said. “The question really is will we be better prepared for Covid and other health threats going forward, and the jury is very much still out on that,” he said.
The CDC estimated last spring that nearly 187 million people in the U.S. had caught Covid at least once through February 2022, more than double the number of officially reported cases at the time. The estimate was based on a survey of commercial lab data that found about 58% of Americans had antibodies as a result of a Covid infection. The survey did not account for re-infections or antibodies from vaccination.
The CDC has subsequently recorded more than 21 million confirmed cases from March through Dec. 21 of this year, although this is an underestimate because people who use rapid tests at home are not picked up in the data.
The more than 21 million additional confirmed cases on top of the CDC’s February estimate of about 187 million total infections gives a low-end estimate of more than 208 million infections since the pandemic began.
“It’s really hard to stop this virus, and that’s one of the reasons why we’ve shifted the focus to hospitalizations and deaths and not just counting cases,” said Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at Brown University School of Public Health.
The U.S. has made significant progress since the darkest days of the pandemic. Deaths have dropped about 90% from the pandemic peak in January 2021 when more than 3,000 people were succumbing to the virus daily before widespread vaccination. Daily hospital admissions are down 77% from a peak of more than 21,000 in January 2022 during the massive omicron surge.
Despite this progress, deaths and hospitalizations remain stubbornly high given the widespread availability vaccines and treatments. About 400 people are still dying a day from the virus and about 5,000 are admitted to the hospital daily. The virus is still circulating at what would have been considered a high level earlier in the pandemic, with nearly 70,000 confirmed cases reported a day on average, a significant undercount due to testing at home.
More than a million people have died in the U.S. from Covid since the pandemic began, more than any another country in the world.
“I think people have gotten hardened to it,” Frieden said of Covid’s toll. “Covid is a new bad thing in our environment, and it’s likely to be here for the long term. We don’t know how this will evolve, whether it will get less virulent, more virulent — have years that get better and worse.”
White House chief medical advisor Dr. Anthony Fauci, who is stepping down this month, has said the U.S. can consider the pandemic over when Covid hospitalizations and deaths decline to a level similar to the burden from the flu.
For the first, the two viruses are circulating simultaneously at high levels. From October through the first week of December, flu killed 12,000 people while Covid took more than 27,000 lives during that period.
“We’re still in the middle of this — it is not over,” Fauci told the radio show “Conversations on Health Care” in November. “Four hundred deaths per day is not an acceptable level. We want to get it much lower than that.”
Frieden said 95% of people who are dying from Covid aren’t up to date on their shots and 75% of people who would benefit from the antiviral Paxlovid are not receiving it.
“We should celebrate these great tools we have, but we’re not doing a good job of getting getting them into people and that would not just save lives, but reduce the disruption from from Covid,” he said.
Dr. Ashish Jha, the White House Covid taskforce coordinator, has said people who are up to date on their vaccines and get treated when they have a breakthrough infection face almost no risk of dying from Covid at this point in the pandemic. Jha has called on the older Americans in particular, who are more vulnerable to severe illness, to get boosted so they have more protection during the holidays.
“There are still too many older Americans who have not gotten their immunity updated who have not gotten themselves protected,” Jha told reporters at the White House last week.
Michael Osterholm, a leading epidemiologist, said new Covid variants will pose the biggest threat to progress the U.S. has made in 2023.
China has eased its stringent zero Covid policy, which sought to crush outbreaks of the virus, in response to widespread social unrest during the fall. Infections are now soaring in the country, raising concern that Covid now has even more space to mutate.
The virus has continued to mutate into ever more transmissible versions of omicron over the past year, at the same time that immunity from vaccination or prior infection has waned off.
“We want to believe that after three years of activity, all the immunity that we should have acquired through either vaccination or previous infection should protect us,” said Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “But with waning immunity and the variants — we can’t say that.”
