sBLA for Alzheimer's drug set for swift review

6 March 2023

Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) have announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use.

This filing supports the conversion of the accelerated approval of the Alzheimer’s drug to a traditional authorization.

Eisai’s Leqembi application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

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