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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.