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FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM, pronounced "I Click") for maintenance dosing. LEQEMBI IQLIK is a subcutaneous autoinjector (SC-AI) developed by Ei
About this update from Eisai Co., Ltd.
[{"type":"text","content":"LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 monthsLEQEMBI IQLIK will be launched on October 6th, 2025, in the U.S.","length":286,"tagName":"p","attribs":{}},{"type":"text","content":"TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM, pronounced "I Click") for maintenance dosing. LEQEMBI IQLIK is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of LEQEMBI (lecanemab-irmb) intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.","length":1197,"tagName":"p"},{"type":"image","alt":"Eisai logo and Biogen logo (PRNewsfoto/Eisai Co., Ltd.)","displaySize":"","headline":null,"caption":"Eisai logo and Biogen logo (PRNewsfoto/Eisai Co., Ltd.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":112,"url":"https://media.zenfs.com/en/prnewswire.com/8fbe328e0f2d5337d2839c8345101b15"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/0o85llr4k4YPB6fanxtHPg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5NztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/8fbe328e0f2d5337d2839c8345101b15","width":400,"height":112}},"href":"https://mma.prnewswire.com/media/723010/Eisai_Logo_and_Biogen_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Clinical Trials Supporting Subcutaneous Maintenance Dosing App...