FDA Grants First Full Approval For an Alzheimer's Drug In 20 Years
An anonymous reader quotes a report from Politico: The FDA on Thursday granted traditional approval to an Alzheimer's drug for the first time in more than two decades. Now, the question becomes how many people will be able to access the drug, which is targeted at patients in the early stages of the debilitating disease. Medicare has said that it will reimburse the drug's costs -- more than $26,000 annually -- only for beneficiaries enrolled in a nationwide registry that tracks patient side effects and outcomes over time. Patient advocacy groups and some clinicians fear this means that few of the hundreds of thousands of Alzheimer's patients eligible for the treatment will be able to access it. The agency previously granted Leqembi, developed and manufactured by Eisai and Biogen, accelerated approval before evaluating late-stage clinical trial data earlier this year. The drug moderately slowed trial participants' cognitive decline compared to a placebo, according to the data, but had potentially serious side effects, including brain swelling and bleeding. Under accelerated approval, the Centers for Medicare and Medicaid Services said it would cover Leqembi only for those participating in a randomized clinical trial, of which none were enrolling. Medicare's coverage determination was contrary to the Veterans Health Administration, which said it would cover the drug for its beneficiaries without restriction. Roughly 6.7 million people in the U.S. have Alzheimer's, and there are few treatments for the disease. Aduhelm, a drug from Biogen that received accelerated approval in 2021, works similarly to Leqembi by targeting proteins thought to be one of the causes of the disease. But both drugs have received little uptake due to Medicare coverage restrictions, and patient and caregiver concerns over the evidence of its modest benefits. There are five existing treatments for Alzheimer's that treat some of the disease's symptoms, but do not slow progression of the disease.
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