Lecanemab Fails to Get EU Marketing Approval; Eisai to Seek Reexamination
By Denny Jacob
Biogen and Eisai disclosed that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a negative opinion on marketing authorization approval for early Alzheimer's disease treatment Lecanemab.
Eisai said it will seek reexamination of the opinion and its Chief Clinical Officer, Lynn Kramer, stated that the company was extremely disappointed by the Committee for Medicinal Products for Human Use's negative opinion.
The biopharmaceutical company's Lecanemab is already approved in the U.S., Japan, China and other countries. It's being marketed in the U.S., Japan and China.
Eisai serves as the lead for Lecanemab's development and regulatory submissions globally. Both Eisai and Biogen co-commercialize and co-promote the product, while Eisai has final decision making authority.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
July 26, 2024 08:15 ET (12:15 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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