FDA Panel Recommends Approval of Eli Lilly's Alzheimer’s Drug

A Food and Drug Administration advisory panel unanimously voted to recommend Eli Lilly’s Alzheimer’s drug donanemab for approval. The panel's 11 members endorsed donanemab, citing benefits that outweigh the drug’s risks of brain swelling and bleeding. A final approval from the FDA would make donanemab the second drug of its kind to be authorized in the U.S. A phase three trial of Donanemab involving more than 1,700 patients found the drug slowed the progression of Alzheimer’s by 29% over 18 months. The FDA advisory committee voted 11-0 that donanemab is effective at slowing down Alzheimer’s in the disease’s early stages and that the drug’s benefits outweigh its risks. If the FDA follows the committee’s recommendation, donanemab would join a similar drug, Leqembi, which was approved by the agency in 2023. Critics of donanemab are concerned about the severity of side effects that may appear to be stroke-like symptoms. The FDA is expected to make the final decision on the drug’s approval within the year or early next spring.