US FDA to Review Eli Lilly’s Donanemab for Early Alzheimer’s Treatment
The meeting is set to be held on June 10, 2024
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.
very good !!!