FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

1. The FDA has postponed its decision on Eli Lilly's Alzheimer's drug, donanemab, surprising both the company and experts who expected approval this month.
2. The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the safety and efficacy of donanemab.
3. The exact date for the advisory committee meeting is not yet known, and the decision will now occur at least into the second quarter of 2024.
4. Lilly's clinical trial of more than 1,700 people found that donanemab slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s by 35% at 76 weeks compared to those who took a placebo.
5. Side effects of donanemab include brain swelling in 24% of treated patients and brain bleeding in 31.4% of the treated group, with three participants dying from brain swelling.
6. If approved, donanemab would become the third Alzheimer’s drug in its class to hit the market in the United States, following Leqembi and Aduhelm.
7. The FDA previously rejected donanemab's bid for accelerated approval due to the innovative design of the trial allowing patients to discontinue treatment after achieving certain thresholds.
8. The FDA held advisory committee meetings for both Leqembi and Aduhelm, indicating that the committee meeting for donanemab follows a precedent set for other FDA-approved amyloid-targeting Alzheimer’s therapies.