FDA initially denied approval for Eli Lilly's Alzheimer's drug Donanemab due to safety and efficacy concerns.

An investigation by The BMJ raises significant concerns about Eli Lilly's Alzheimer's drug, Donanemab, which was approved by the FDA despite issues regarding safety, efficacy, and conflicts of interest among advisory panelists. The FDA initially denied approval, citing high rates of missing data and treatment discontinuation due to adverse events. Despite lacking clinically meaningful results, Lilly claimed Donanemab slowed disease progression, raising skepticism among experts.

September 25, 2024
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