U.S. FDA extends review period for Biogen's Alzheimer's drug

[January 29, 2021]    (Reuters) - Biogen Inc and partner Eisai Co Ltd said on Friday the U.S. Food and Drug Administration has extended the review period for their experimental Alzheimer's disease treatment by three months.

Biogen's shares rose 8% premarket.

The FDA will now decide on the marketing application for the drug, aducanumab, by June 7. An FDA panel in November had voted against approval of the drug.

Biogen submitted the aducanumab marketing application to the FDA in July 2020.

(Reporting by Manojna Maddipatla, Dania Nadeem and Manas Mishra in Bengaluru; Editing by Shounak Dasgupta)

[© 2021 Thomson Reuters. All rights reserved.]

Copyright 2021 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.