FDA Accepts LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease under Priority Review

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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, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease","length":191,"tagName":"p"},{"type":"text","content":"FDA action date set for May 24, 2026","length":36,"tagName":"p"},{"type":"text","content":"TOKYO and CAMBRIDGE, Mass., Jan. 25, 2026 (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 the U.S. Food and Drug Administration (FDA) has accepted for review Eisai’s Supplemental Biologics License Application (sBLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. ","length":829,"tagName":"p"},{"type":"text","content":"Should the FDA approve the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of SC or IV administration throughout the entire treatment journey. The injection time for LEQEMBI IQLIK autoinjector takes approximately 15 seconds per each 250 mg injection. The SC formulation also has the pote...

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