FX.co ★ FDA Advisory Committee To Convene Meeting To Discuss On Eli Lilly's Alzheimer's Drug

Eli Lilly and Company, a leading pharmaceutical firm, revealed Tuesday that an Advisory Committee from the U.S. Food and Drug Administration (FDA) will hold a meeting to discuss Donanemab, a proposed treatment for early symptomatic Alzheimer's disease.

This discussion will be orchestrated by the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS). On Monday, June 10, 2024, the committee will assess the merits of Donanemab, which Eli Lilly has put forth as a potential solution for those in the early stages of symptomatic Alzheimer's. The proceedings for the public hearing section of the meeting will be carried out virtually.

The application presented by Eli Lilly includes the TRAILBLAZER-ALZ 2 study, a double-blind, placebo-controlled evaluation that scrutinized the safety and effectiveness of Donanemab on subjects aged between 60 and 85 years, who are diagnosed with early symptomatic Alzheimer's disease and confirmed Alzheimer's neuropathology.

Alzheimer's disease is a fatal, progressive disorder that at the early symptomatic stage affects approximately 6 to 7.5 million Americans.

About 1,736 participants were enrolled in the trial, from eight different countries, chosen using cognitive assessments together with amyloid plaque imaging and tau staging, conducted through positron emission tomography (PET) imaging techniques.