ARTICLE | Regulation
What may be on FDA’s agenda as it calls for panel on Lilly’s Alzheimer’s mAb
With FDA scheduling an advisory committee meeting, donanemab will miss its PDUFA date this month
March 9, 2024 2:29 AM UTC
FDA approval of Eli Lilly’s Alzheimer’s therapy is not in doubt, but the agency’s last-minute decision to hold an advisory committee meeting suggests it may be mulling questions about the product’s labeling.
One concern likely on investors’ minds is whether the company’s sophisticated biomarker strategy, which has been highly informative for the field, will result in a narrower label for donanemab than its competitor Leqembi lecanemab, marketed by Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB)...