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Biogen: FDA accepts application for LEQEMBI

(CercleFinance.com) - Eisai and Biogen yesterday announced that the US FDA has accepted Eisai's supplemental Biologics License Application (sBLA) for traditional approval of LEQEMBI, for the treatment of Alzheimer's disease.


LEQEMBI's application received priority review, with an action date of 6 July 2023.
The FDA plans to convene an advisory committee to discuss the application, but has not yet publicly announced the date of the meeting.

LEQEMBI was approved under an accelerated approval in the US and was launched in that country on 18 January 2023.


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