US FDA to Review Eli Lilly’s Donanemab for Early Alzheimer’s Treatment

 The US Food and Drug Administration (FDA) will convene an in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on Monday, June 10, 2024, to discuss donanemab, which Eli Lilly and Company (NYSE: LLY) has submitted for the treatment of early symptomatic Alzheimer’s disease. The open public hearing portion of the meeting will be conducted virtually. 

As per the company’s statement, the Phase 3 study submitted as part of this application, TRAILBLAZER-ALZ 2, is a double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants ages 60-85 years with early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease) with the presence of confirmed Alzheimer’s disease neuropathology. 

The TRAILBLAZER-ALZ study results were published in the Journal of the American Medical Association (JAMA).

 Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ-3, studying donanemab for the prevention of Alzheimer’s disease.