FDA accepts filing of a supplemental BLA and grants priority review for traditional approval of Leqembi to treat Alzheimer's disease. Eisai
Eisai Co., Ltd. and Biogen Inc. announced that the FDA has accepted Eisai’s supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of Leqembi to a traditional approval.
The Leqembi application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
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