FDA Panel Unanimously Backs Eli Lilly's Alzheimer's Drug Donanemab in 11-0 Vote

Jun 10, 2024, 07:47 PM

Eli Lilly's experimental Alzheimer's drug, donanemab, has received unanimous backing from an FDA advisory panel. The panel voted 11-0 in favor of the drug's efficacy, stating that its benefits outweigh the risks, despite concerns about brain bleeding and swelling, particularly in APOE4 carriers. This recommendation paves the way for potential full approval of donanemab in the United States later this year. The drug was shown to significantly slow clinical progression of Alzheimer's disease in the TRAILBLAZER-ALZ 2 trial, which was published in JAMA. The panel also reviewed safety risks and the design of clinical trials. Eli Lilly's shares rose 2% following the panel's vote.