Eli Lilly (NYSE: LLY) has announced a delay in the action date for its Alzheimer’s disease candidate, donanemab, with the U.S. Food and Drug Administration (FDA) pushing the timeline beyond the fourth quarter of 2024. The delay follows the FDA’s request for an advisory committee meeting to evaluate donanemab’s Phase III trial results in patients with early symptomatic Alzheimer’s disease.
The meeting will focus on safety outcomes and trial design elements, including treatment regimen length and participant eligibility criteria. Although participants across all groups experienced some benefits from the treatment, donanemab has been linked to serious risks, including potentially fatal amyloid-related imaging abnormalities (ARIA).
Lilly pointed out that both FDA-approved amyloid plaque-targeting therapies—Eisai’s (TYO: 4523) Leqembi (lecanemab) and Biogen’s (NASDAQ: BIIB) now-discontinued Aduhelm (aducanumab)—also underwent advisory committee reviews in the past.- Flcube.com
