ARTICLE | Regulation
Leqembi marks fifth disagreement between FDA and CHMP on neurology medicines
Next up for comparison will be Alzheimer’s therapy donanemab, which FDA approved in June and CHMP is reviewing
July 27, 2024 12:57 AM UTC
Updated on Jul 27, 2024 at 3:44 AM UTC
CHMP issued a negative opinion Friday recommending against approval of Leqembi to treat early Alzheimer’s disease, the fifth time in the last several years that the European regulator has rejected a drug for a neurodegenerative disease that FDA had approved.
Eisai Co. Ltd. (Tokyo:4523), which is responsible for the application for Leqembi lecnemab, said it would request a re-examination of the decision. It has a 50-50 cost and profit-sharing agreement with Biogen Inc. (NASDAQ:BIIB) on the therapy...