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Tag: Incretin

  • Lilly Releases Zepbound Single-Dose Vials for Adults Living with Obesity

    Lilly Releases Zepbound Single-Dose Vials for Adults Living with Obesity

    Eli Lilly and Company released Zepbound (tirzepatide) 2.5 mg and 5 mg single-dose vials for adults living with obesity, and announced the medicines are available for self-pay for patients with an on-label prescription. The company said it significantly expands the supply of Zepbound in response to high demand.

    The single-dose vials are priced at a 50% or greater discount compared to the list price of all other incretin (GLP-1) medicines for obesity. This new option helps millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage, and those who need to self-pay outside of insurance.

    “We are excited to share that the Zepbound single-dose vials are now here, further delivering on our promise to increase supply of Zepbound in the U.S.,” said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. “These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option. In a clinical study, the 5 mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off.”

    Lilly has created a new self-pay pharmacy component of LillyDirect where patients with a valid, on-label prescription from the health care provider of their choice can purchase the vials. Distributing the vials via this channel ensures patients and providers can trust they are receiving genuine Lilly medicine, building on the company’s efforts to help protect the public from the dangers posed by the proliferation of counterfeit, fake, unsafe or untested knock-offs of Lilly’s medications.

    Lilly has also taken a vocal stance against the use of obesity medicine for cosmetic weight loss; a multi-step verification process will help ensure the vials are dispensed only to patients who have a valid, on-label electronic prescription from their health care provider. Patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.

    “People living with obesity have long been denied access to the essential treatment and care needed to manage this serious chronic disease,” said James Zervos, chief operating officer, Obesity Action Coalition. “Expanding coverage and affordability of treatments is vital to people living with obesity. We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality. Now, it’s time for policymakers, employers and insurers to work with pharmaceutical companies to ensure no one is left behind in receiving the care they deserve and need.”

    A four-week supply of the 2.5 mg Zepbound single-dose vial is $399 ($99.75 per vial), and a four-week supply of the 5 mg dose is $549 ($137.25 per vial) – less than half the list price of other incretin medicines for obesity and in line with the Zepbound savings program for non-covered individuals. The self-pay channel enables a transparent price by removing third-party supply chain entities and allowing patients to access savings directly outside of insurance.

    “Despite obesity being recognized as a serious chronic illness with long-term consequences, it’s often misclassified as a lifestyle choice, resulting in many employers and the federal government excluding medications like Zepbound from insurance coverage,” said Jonsson. “Outdated policies and lack of coverage for obesity medications create an urgent need for more innovative solutions. Bringing Zepbound single-dose vials to patients will help more people living with obesity manage this chronic condition. We will also continue to advocate for a system that better aligns with the science.”

    In a clinical study, tirzepatide 5 mg, along with a reduced calorie diet and increased physical activity, achieved an average of 15% weight loss over 72 weeks compared to 3.1% for placebo. Zepbound is the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or those who are overweight and also have weight-related medical problems, to lose weight and keep it off. Zepbound should be used with a reduced-calorie diet and increased physical activity. It should not be used in children under 18 years of age or with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. Zepbound has not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis, and it is unknown if patients with a history of pancreatitis are at higher risk for developing pancreatitis on Zepbound.

    Zepbound is also available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 ml doses in a single-dose pen (autoinjector). The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.

    To learn more about the Zepbound® single-dose vial, please visit Lilly online.

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  • Next Gen Weight Loss Drugs Are Coming for Ozempic’s Throne

    Next Gen Weight Loss Drugs Are Coming for Ozempic’s Throne

    The future of weight loss is fast approaching. At a recent scientific conference, drug companies showed off a variety of next-generation drugs for both obesity and type 2 diabetes. Some of these treatments might help people lose even more weight than current forerunners like Novo Nordisk’s semaglutide—the active ingredient in popular drugs Ozempic and Wegovy—while others may come with fewer side effects or be easier to take.

    Semaglutide is a drug that mimics GLP-1, one of several hormones that help regulate our sense of hunger and blood sugar. In clinical trials, semaglutide has proven to be much more effective at treating obesity than diet and exercise alone. Previously only approved for type 2 diabetes as Ozempic, semaglutide was approved for obesity in 2021 under the name Wegovy. However, it’s already started to be overshadowed by the arrival of Eli Lilly’s tirzepatide, which combines GLP-1 with another incretin hormone called GIP. Tirzepatide was approved by the Food and Drug Administration in 2021 for type 2 diabetes under the brand name Mounjaro; in November 2023, it was approved to treat obesity as Zepbound.

    Newer treatments in the works are poised to compete with and possibly surpass both of these drugs. The American Diabetes Association held its annual conference over the past weekend, and the emergence of these future medications was a big aspect of the event. Companies presented preliminary data on over two dozen GLP-1 related drugs, all in various stages of development.

    “We’ve heard about Ozempic and Mounjaro and so on, but now we’re seeing lots and lots of different drug candidates in the pipeline, from very early-stage preclinical all the way through late-stage clinical,” Marlon Pragnell, ADA’s vice president of research and science, told NBC News. “It’s very exciting to see so much right now.”

    Altimmune’s pemvidutide, for instance, combines GLP-1 with glucagon, another hormone key to keeping our blood sugar level stable. In Phase II trial data presented this weekend, pemvidutide was found to help people lose over 15% of their baseline weight within 48 weeks, a bit ahead of the pace seen with semaglutide (15% weight loss over 68 weeks). A dual GLP-1/GIP candidate developed by scientists in China, called HRS9531 for now, was found to cause up to 16% weight loss within 24 weeks. Eli Lilly also presented new data on its second-generation drug retatrutide, which combines GLP-1, GIP, and glucagon, finding it improved insulin’s ability to control blood sugar in people with type 2 diabetes. In previous research, retatrutide was found to cause up to 24% weight loss, the highest mark seen yet with these drugs.

    It’s not certain that these or other GLP-1 drugs in development will truly outmatch semaglutide and tirzepatide in terms of weight loss, but they may still have other benefits over them. Pemvidutide was found to cause less lean body mass loss, for instance, possibly due to the addition of glucagon (exercise naturally raises glucagon levels, so the drug could be mimicking some of the positive effects of exercise). Some experts are skeptical that lean body mass loss is a major concern with these drugs. However, it may be important to prevent this in individuals who are more vulnerable to muscle or bone loss, such as older adults.

    It will take years for these newer drugs to reach the public, assuming they continue to succeed in larger trials. Their arrival may not only help people who don’t respond to existing treatments, though, but could also drive down the overall high costs of these medications (without insurance coverage, which is often denied, a month’s supply of semaglutide can reach over $1,000 per month).

    “Over the past few years, we have seen the substantial impact of new research working to solve the dual health crisis we are facing, obesity and diabetes,” said Robert Gabbay, chief scientific and medical officer for the ADA, in a statement from the ADA. “The studies we are seeing presented at this year’s annual meeting show great promise to fuel new solutions and treatment options for patients across the globe living with type 2 diabetes and obesity.”

    Ed Cara

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