Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease U

By Eisai Inc., Biogen Inc.

LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease

TOKYO and CAMBRIDGE, Mass. , Sept. 2, 2025 /PRNewswire/ -- 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 initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI ® ) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly st