Eisai and Biogen announced that the U.S. FDA has accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMB (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to traditional approval. The LEQEMBI application is based on the confirmatory Phase 3 Clarity AD data and has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.  LEQEMBI is a humanized...