Eisai Completes Rolling Submission to US FDA for LEQEMBI® (lecanemab-irmb)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, „Eisai“) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, „Biogen“) announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set.