Eisai, Biogen say FDA grants priority review for Alzheimer's drug Lecanemab

Send a link to a friend  Share

[March 06, 2023]  TOKYO (Reuters) - Japanese drugmaker Eisai Co Ltd and its U.S. partner Biogen Inc said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer's treatment Lecanemab.

The FDA accepted Eisai's supplemental Biologics License Application for the drug, supporting transition from the accelerated approval granted in January, the drugmaker said in a statement.

(Reporting by Rocky Swift; editing by Diane Craft)

[to top of second column]

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS

 

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.

Back to top