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Leqembi? (lecanemab) Authorized for Early Alzheimer’s Disease in Great Britain

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 the humanized amyloid-beta (Aβ) monoclonal antibody “Leqembi?” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great […]

Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI? (lecanemabirmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Under the Fast Track Status

Eisai and Biogen announced today that Eisai has initiated 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.