FDA Advisory Committee Unanimously Approves Eli Lilly's Alzheimer's Drug as Safe and Effective

Benzinga 2024-06-11

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An FDA advisory committee voted unanimously that Eli Lilly's Alzheimer's drug donanemab is safe and effective for treating early-stage Alzheimer's disease. The drug works by helping the body remove amyloid plaque buildup in the brain, that are a hallmark of Alzheimer's disease. In clinical trials, the drug reduced the risk of Alzheimer's progression by 37% over 18 months compared to a placebo. Three patients died from microhemorrhages while on donanemab. The advisory committee voted that donanemab's benefits outweighed its risks for patients enrolled in the clinical trials.

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