LLY - Eli Lilly's Donanemab For Alzheimer's Hits FDA Speed Breaker Biogen Stock Gains On Delayed Decision | Benzinga
The FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly and Company’s (NYSE:LLY) 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, including its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the