FDA Advisory Committee To Convene Meeting To Discuss On Eli Lilly's Alzheimer's Drug

(RTTNews) - Eli Lilly and Company (LLY) Tuesday announced that the U.S. Food and Drug Administration's Advisory Committee will convene a meeting on Donanemab for early symptomatic Alzheimer's disease.

The Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) will convene a meeting on Monday, June 10, 2024, to discuss Donanemab, which Eli Lilly has submitted for the treatment of early symptomatic Alzheimer's disease. The open public hearing portion of the meeting will be conducted virtually.

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 with the presence of confirmed Alzheimer's disease neuropathology.

Alzheimer's disease is a progressive and fatal disease that in its early symptomatic stages affects 6-7.5 million Americans.

The trial enrolled 1,736 participants, across eight countries, selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by positron emission tomography (PET) imaging.