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Tag: drug safety

  • Semaglutide fails to slow progression of Alzheimer’s in highly anticipated trials, Novo Nordisk says

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    An oral version of semaglutide, the active ingredient in blockbuster drugs Ozempic and Wegovy, failed to slow the progression of Alzheimer’s disease in closely watched trials, Novo Nordisk said Monday.In two Phase 3 trials of more than 3,800 adults receiving standard care for Alzheimer’s, the company evaluated whether an older pill form of semaglutide worked better than a placebo. The drug was shown to be safe and led to improvements in Alzheimer’s-related biomarkers, the company said, but the treatment did not delay disease progression.Novo had long treated Alzheimer’s as a long-shot bet for the popular GLP-1 drugs. Use of these drugs for diabetes and weight loss has exploded in recent years, and they have shown benefits for a wide range of additional health conditions, such as protecting the heart and kidneys, reducing sleep apnea and potentially helping with addiction.Smaller trials and animal studies had suggested GLP-1s might help slow cognitive decline or reduce neuro-inflammation but larger trials like Novo’s were needed to confirm whether patients saw actual benefits.”Based on the significant unmet need in Alzheimer’s disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” said Martin Holst Lange, chief scientific officer and executive vice president of Research and Development at Novo Nordisk said in a statement on Monday that thanked trial participants.A one-year extension of the trials will be discontinued, Novo said. Results from the trials have not yet been peer-reviewed or published but will be presented at upcoming scientific conferences.Novo has been facing increased competition in the weight loss market and recently announced lowered prices for some cash-paying patients using Ozempic and Wegovy. Novo shares fell Monday after the Alzheimer’s trial announcement.

    CNN —

    An oral version of semaglutide, the active ingredient in blockbuster drugs Ozempic and Wegovy, failed to slow the progression of Alzheimer’s disease in closely watched trials, Novo Nordisk said Monday.

    In two Phase 3 trials of more than 3,800 adults receiving standard care for Alzheimer’s, the company evaluated whether an older pill form of semaglutide worked better than a placebo. The drug was shown to be safe and led to improvements in Alzheimer’s-related biomarkers, the company said, but the treatment did not delay disease progression.

    Novo had long treated Alzheimer’s as a long-shot bet for the popular GLP-1 drugs. Use of these drugs for diabetes and weight loss has exploded in recent years, and they have shown benefits for a wide range of additional health conditions, such as protecting the heart and kidneys, reducing sleep apnea and potentially helping with addiction.

    Smaller trials and animal studies had suggested GLP-1s might help slow cognitive decline or reduce neuro-inflammation but larger trials like Novo’s were needed to confirm whether patients saw actual benefits.

    “Based on the significant unmet need in Alzheimer’s disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” said Martin Holst Lange, chief scientific officer and executive vice president of Research and Development at Novo Nordisk said in a statement on Monday that thanked trial participants.

    A one-year extension of the trials will be discontinued, Novo said. Results from the trials have not yet been peer-reviewed or published but will be presented at upcoming scientific conferences.

    Novo has been facing increased competition in the weight loss market and recently announced lowered prices for some cash-paying patients using Ozempic and Wegovy. Novo shares fell Monday after the Alzheimer’s trial announcement.

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  • FDA says drug makers have recalled a blood pressure medicine tainted with a cancer-causing chemical

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    The U.S. Food and Drug Administration says drug makers have recalled more than a half-million bottles of the blood pressure medication prazosin hydrochloride over concerns it may include a cancer-causing chemical.New Jersey-based Teva Pharmaceuticals USA and drugs distributor Amerisource Health Services issued voluntary nationwide recalls earlier this month of more than 580,000 bottles of various strengths of prazosin capsules, according to the FDA.Doctors prescribe prazosin, which relaxes blood vessels, to help lower blood pressure. It also is sometimes prescribed for nightmares and other sleep disturbances caused by post-traumatic stress disorder.The FDA said in enforcement orders posted online that it has given the affected lots of the drug a Class II risk classification because some of the recalled medication may have nitrosamine impurities that are considered potentially cancer causing.According to the FDA, N-nitrosamine impurities are a class of potentially cancer-causing chemicals that can form during manufacture or storage of a drug.

    WASHINGTON —

    The U.S. Food and Drug Administration says drug makers have recalled more than a half-million bottles of the blood pressure medication prazosin hydrochloride over concerns it may include a cancer-causing chemical.

    New Jersey-based Teva Pharmaceuticals USA and drugs distributor Amerisource Health Services issued voluntary nationwide recalls earlier this month of more than 580,000 bottles of various strengths of prazosin capsules, according to the FDA.

    Doctors prescribe prazosin, which relaxes blood vessels, to help lower blood pressure. It also is sometimes prescribed for nightmares and other sleep disturbances caused by post-traumatic stress disorder.

    The FDA said in enforcement orders posted online that it has given the affected lots of the drug a Class II risk classification because some of the recalled medication may have nitrosamine impurities that are considered potentially cancer causing.

    According to the FDA, N-nitrosamine impurities are a class of potentially cancer-causing chemicals that can form during manufacture or storage of a drug.

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