INDIANAPOLIS - Eli Lilly and Company (NYSE: NYSE:LLY) announced today that the U.S. Food and Drug Administration (FDA) plans to assemble its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial results for donanemab, an investigational Alzheimer's drug. The date for the advisory committee meeting has not been determined, which has postponed the expected FDA decision on the drug beyond the first quarter of 2024.
The TRAILBLAZER-ALZ 2 trial is a significant study that has evaluated the safety and efficacy of donanemab in individuals aged 60-85 with early symptomatic Alzheimer's disease. The trial included 1,736 participants across eight countries and utilized a unique trial design, including a limited-duration dosing regimen and participant selection based on tau levels.
Donanemab treatment has shown benefits for all trial participants, with those in earlier disease stages experiencing more pronounced effects. The treatment also allowed nearly half of the participants to complete their treatment within six or 12 months. However, the drug is associated with risks such as amyloid-related imaging abnormalities (ARIA), which can be severe.
The study's findings were published in the Journal of the American Medical Association (JAMA), and donanemab continues to be evaluated in multiple clinical trials. Despite the delayed FDA review process, this development has not impacted Eli Lilly's financial outlook for 2024.
Eli Lilly, with a history stretching nearly 150 years, is focused on addressing significant global health challenges, including Alzheimer's disease. The company emphasizes the importance of diverse clinical trials and seeks to ensure its medicines are accessible and affordable.
The announcement of the FDA's upcoming advisory committee meeting is based on a press release statement from Eli Lilly and Company.
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