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

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.