On January 13, 2025, Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for August 31, 2025, providing a clear timeline for a potential regulatory decision. If approved, LEQEMBI would become the only AD treatment that can be administered subcutaneously at home using an autoinjector, with the injection process expected to take approximately 15 seconds.
This new formulation is designed to maintain the clinical and biomarker benefits observed with intravenous administration, potentially simplifying treatment and reducing the need for hospital or infusion site visits. The BLA is based on data from the Clarity AD (Study 301) open-label extension and modeling of observed data, aiming to enhance convenience and adherence for patients and their care partners.
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