FDA to Review Lilly’s Alzheimer’s Drug Donanemab in June Advisory Committee Meeting

1. The U.S. Food and Drug Administration (FDA) has scheduled a June advisory committee meeting to review Eli Lilly and Company's (Lilly) Alzheimer's drug, donanemab.
2. Donanemab is an investigational antibody that targets a modified form of beta-amyloid called N3pG. It aims to reduce amyloid plaques in the brain, which are associated with Alzheimer's disease.
3. The FDA's advisory committee, composed of independent experts, will evaluate the safety and efficacy data of donanemab and provide recommendations to the agency regarding its potential approval.
4. If approved, donanemab could become the third FDA-approved treatment for Alzheimer's disease, following Biogen's Aduhelm and Eisai's Leqembi.
5. Lilly has submitted a Biologics License Application (BLA) to the FDA for donanemab under the accelerated approval pathway, based on Phase 2 clinical trial data.
6. The Phase 2 trial, called TRAILBLAZER-ALZ, demonstrated that donanemab significantly slowed cognitive decline in patients with early symptomatic Alzheimer's disease.
7. The FDA's decision on donanemab is expected by early 2024, following the June AdCom meeting and the agency's review of the BLA.
8. Donanemab's potential approval could provide a new treatment option for patients with Alzheimer's disease, a progressive neurodegenerative disorder that affects memory, thinking, and behavior.