The FDA is set to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly and Company’s Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer’s disease.
The FDA has informed Lilly that it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study. This includes its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels.
The date of the advisory committee meeting for donanemab has yet to be set by the FDA, resulting in a delay in the timing of expected FDA action on donanemab beyond the first quarter of 2024. While it is unusual for an advisory committee to occur after the anticipated FDA action date, the advisory committee meeting for donanemab follows similar meetings for two other amyloid plaque-targeting therapies the FDA has approved.
Anne White, executive vice president of Eli Lilly and president of Lilly Neuroscience, expressed confidence in donanemab’s potential to offer significant benefits to people with early symptomatic Alzheimer’s disease. She stated that while it was unexpected for the FDA to convene an advisory committee at this stage in the review process, they look forward to presenting the TRAILBLAZER-ALZ 2 results and highlighting donanemab’s strong efficacy in the context of safety.
The news of the FDA delaying its decision for Eli Lilly’s Alzheimer’s drug has had an impact on the market, with Biogen Inc shares trading higher in reaction to this development. Donanemab would compete with Eisai Co Ltd/Biogen’s Leqembi, for which the FDA granted standard authorization last year.
Overall, the FDA’s decision to convene an advisory committee meeting for donanemab adds an element of uncertainty to the timeline for potential approval of the drug. It will be interesting to see how this development affects the competitive landscape in the Alzheimer’s disease treatment market and what implications it may have for other players in the field.
