FDA Grants Full Approval For Alzheimer's Drug, Despite Concerns


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The Food and Drug Administration granted full approval for Biogen and Eisai’s anti-Alzheimer’s drug lecanemab, the first of its kind to slow Alzheimer’s Disease, just six months after it received accelerated approval, though experts have expressed concern over severe and potentially fatal side effects of the drug.

Key Facts

Lecanemab, which is made by Biogen and Japanese drugmaker Eisai, received full approval after the FDA determined through a series of trials it has a “verified clinical benefit,” the agency announced in a statement, making the drug the first Alzheimer’s treatment with full approval through the FDA.

The drug, marketed as Leqembi, had received accelerated approval in January, despite concerns from experts outside the FDA who warned the drug could induce potentially fatal brain swelling and bleeding, and after a death was reported in a clinical trial of the drug.

Leqembi, which clears plaque in the brain that contributes to cognitive decline among older adults with dementia, costs $26,500 per year before insurance, according to Eisai.

What To Watch For

Older adults with Alzheimer’s—which has no known cure—will likely soon be able to access Leqembi through Medicare plans, after the Centers for Medicare and Medicaid Services said last year it would restrict coverage of anti-amyloid drugs that have only accelerated approval, and not full approval, strictly to patients in clinical trials.

Key Background

Leqembi works by reducing protein buildup, called amyloid plaque, in the brain, improving Alzheimer’s patients’ brain functioning. According to an April report from the Institute for Clinical and Economic Review the drug “mildly slows the loss of cognition” among Alzheimer’s patients, though its side effects shown in clinical trials creates “significant uncertainties” over whether its benefits make up for those risks. ICER Chief Medical Officer David Rind said at the time the “first therapy that effectively halts or reverses dementia will warrant a very high price” in the U.S. healthcare market, while another report in the New England Journal of Medicine found it improved cognitive decline in some patients, with decline occurring at a 27% slower rate over 18 months among study participants who took lecanemab in a phase 3 clinical trial.

Big Number

55 million. That’s how many people in the world suffer from dementia, with between 60% and 70% experiencing Alzheimer’s, the most common form of dementia, according to the World Health Organization. Up to 5.8 million of those cases are in the U.S., according to the Centers for Disease Control and Prevention.

Further Reading

The FDA Approved The New Anti-Alzheimer’s Drug Leqembi. What You Need To Know (Forbes)

Lecanemab: How The FDA-Approved Alzheimer’s Drug Works And Its Possible Side Effects (Forbes)

Experts Raise New Questions About The Safety Of Anti-Alzheimer’s Drug Leqembi (Forbes)

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Lisa Holden
Lisa Holden
Lisa Holden is a news writer for LinkDaddy News. She writes health, sport, tech, and more. Some of her favorite topics include the latest trends in fitness and wellness, the best ways to use technology to improve your life, and the latest developments in medical research.

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