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FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review
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
About this update from Biogen Inc.
[{"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 diseaseFDA action date set for May 24, 2026TOKYO and CAMBRIDGE, Mass., Jan. 25, 2026 /PRNewswire/ -- 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. \n \n \n \n \n \n \n \nShould 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 potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring, while streamlining the overall AD treatment pathway.The sBLA is supported by data evaluating SC administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE) following the 18-month core study in individuals with early AD. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks IV administration and similar clinical and biomarker benefits. SC administration demonstrated a safety profile similar to IV admi...