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Nov 28, 2025 4:00 PM

Biogen, Eisai File In Japan To Make Leqembi A Weekly At-Home Alzheimer's Shot

Biogen Inc.‘s (NASDAQ:BIIB) partner Eisai Co., Ltd, on Friday filed a new drug application for Leqembi (lecanemab) seeking approval for a subcutaneous formulation (SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Alzheimer‘s disease (AD) or mild stage of AD dementia.

Once-weekly administration of SC-AI ...