Biogen Inc.’s (BIIB) Japan-based partner, Eisai., announced that it has initiated the rolling submission of a biologics license application (“BLA”) to the FDA seeking approval for Leqembi (lecanemab) subcutaneous (SC) autoinjector as a weekly maintenance dosing for the treatment of early Alzheimer’s disease (AD). Leqembi gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from the Centers for Medicare & Medicaid Services in July 2023. Leqembi is also ...