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FDA Accepts LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration
About this update from Biogen Inc.
[{"type":"text","content":"LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option\nTOKYO and CAMBRIDGE, Mass., Jan. 13, 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 the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. 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). A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025. The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector (AI). The injection process is expected to take, on average, 15 seconds. As part of the SC-AI 360 mg weekly maintenance regimen, patients who have completed the biweekly intravenous (IV) initiation phase, exact period under discussion with the FDA, would receive weekly doses that are expected to maintain the clinical and biomarker benefits. AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque deposition.1,2,3 Only LEQEMBI works to fight AD in two ways by continuously clearing protofibrils and rapidly clearing plaque. With continuous administration, LEQEMBI clears highly toxic protofibrils* which can continue to cause neuronal injury even after amyloid-beta (Aβ) plaque has been cleared from the brain. Long-term three-year LEQEMBI data presented at the Alzheimer’s Association International Conference (AAIC) 2024 suggest that early and continuing treatment may prolong the benefit of therapy even after plaque is cleared from the brain.4 The SC-AI is expected to be simple and easy for patients and their care partners to use, and may reduce the need for hospital...