Upcoming Alzheimer’s Drug Receives Unanimous Support from FDA Advisory Committee

On June 10, the Food and Drug Administration (FDA)’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that Eli Lilly’s donanemab is effective for treating early symptomatic Alzheimer’s disease. The committee, composed of experts who provide independent expert advice to the FDA, also found that the benefits of donanemab outweigh the associated risks of treatment.  

The FDA will consider the favorable vote from the advisory committee as it nears a final decision on whether to approve donanemab. If approved, donanemab will become the second disease-modifying Alzheimer’s therapy to receive traditional approval from the FDA.  

In January 2023, the FDA rejected Lilly’s application for accelerated approval of donanemab, citing an insufficient number of study participants who had received at least 12 months of treatment. Lilly shared the full study results of its Phase 3 trial, TRAILBLAZER-ALZ 2, in July 2023. 

“We are witnessing steady progress in pushing forward disease-modifying therapies for Alzheimer’s,” said Stacy Pagos Haller, President and CEO of BrightFocus Foundation. “Expanding this class of treatments paves the way for enhanced care options and brings hope to the millions of people affected by this mind-stealing disease.” 

About BrightFocus  

BrightFocus Foundation is a premier global nonprofit funder of research to defeat Alzheimer’s, macular degeneration, and glaucoma. Through its flagship research programs — Alzheimer’s Disease Research, National Glaucoma Research, and Macular Degeneration Research — the Foundation has awarded nearly $300 million in groundbreaking research funding over the past 50 years and shares the latest research findings, expert information, and resources to empower the millions impacted by these devastating diseases. Learn more at brightfocus.org.