FDA accepts Eisai's filing for LEQEMBI® monthly IV dosing in early Alzheimer's treatment, with PDUFA action date on Jan 25, 2025.

FDA accepts Eisai's filing of supplemental Biologics License Application for LEQEMBI® (lecanemab-irmb) monthly IV maintenance dosing for early Alzheimer's disease treatment. If approved, the monthly regimen aims to maintain drug concentration to clear toxic protofibrils, potentially reducing burden for patients and care partners. FDA's PDUFA action date is set for January 25, 2025.