Europe to review safety data for Eisai-Biogen Alzheimer's drug (updated)

Eisai

31/01/2025 12:05

(Adds details in paragraphs 2,3 and companies' comment in
paragraph 4 and 5)
       Jan 31 (Reuters) - The European medicines regulator said
on Friday it will review safety information for Eisai  4523.T 
and Biogen's  BIIB.O  Leqembi that the agency recommended for
approval in November for some patients with early Alzheimer's
disease.
    The review is conducted in response to a request from the
European Commission, and may require the agency to update its
previous recommendation for the drug. The agency said it plans
to provide a response to the request in February. 
    The companies or the agency did not provide details on what
safety data will be reviewed. 
    The safety information was made available after the
regulator recommended the drug last year. 
    No new safety signals have been identified with Leqembi,
Biogen and Eisai said in a joint statement. 
    "We believe that the EC's requests can be addressed with
existing information," the companies said. 

 (Reporting by Bhanvi Satija in Bengaluru; Editing by Shinjini
Ganguli)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))