Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan

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[{"type":"image","alt":"Biogen Inc.","displaySize":"","headline":null,"caption":"Biogen Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":101,"url":"https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/wH5zYbm3mC0cXQRHhCXgVw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937","width":300,"height":101}},"lazy":false},{"type":"text","content":"If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, relentless disease","length":186,"tagName":"p"},{"type":"text","content":"TOKYO and CAMBRIDGE, Mass., Nov. 27, 2025 (GLOBE NEWSWIRE) -- 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 Eisai has filed a new drug application for “LEQEMBI®” (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).","length":540,"tagName":"p"},{"type":"text","content":"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 Mild Cognitive Impairment (MCI) due to Alzheimer‘s disease (AD) or mild stage of AD dementia (collectively referred to as early AD). It was confirmed that the once-weekly administration of SC-AI 500mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits. Subcutaneous administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection/infusion-related reactions.","length":730,"tagName":"p"},{"type":"text","content":"If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospita...

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