EISAI COMPLETES ROLLING SUBMISSION TO THE U.S. FDA FOR BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER’S DISEASE UNDER THE ACCELERATED APPROVAL PATHWAY
TOKYO and CAMBRIDGE, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that Eisai has completed the rolling submission to the U.S.
CAMBRIDGE, Mass. and WOODCLIFF LAKE, N.J., June 23, 2021 – Biogen (Nasdaq: BIIB) and Eisai Inc., U.S. subsidiary of Eisai Co., Ltd. today issued the following statement: On June 7, 2021, ADUHELM™ (aducanumab-avwa) 100 mg/mL solution for injection was granted accelerated approval by the U.S. Food and Drug Administration (FDA). We are committed to responding to questions from the Alzheimer’s disease community and providing more details about our plans.