FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023 TOKYO and…