Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

Core Viewpoint - BioArctic AB's partner Eisai has received Priority Review from the U.S. FDA for the supplemental Biologics License Application (sBLA) for Leqembi Iqlik, a subcutaneous autoinjector for Alzheimer's disease treatment, with a PDUFA action date set for May 24, 2026 [1] Group 1: Product Details - Leqembi Iqlik is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, representing early Alzheimer's disease [1] - If approved, Leqembi Iqlik would be the first anti-amyloid treatment allowing at-home injections for both initiation and maintenance dosing [1] - The sBLA is supported by data showing that the 500 mg subcutaneous dosing regimen achieves equivalent exposure to the current bi-weekly intravenous dosing, with similar clinical benefits [3] Group 2: Administration and Benefits - The autoinjector allows for a once-weekly starting dose, providing an alternative to the current bi-weekly intravenous administration [2] - Each injection takes approximately 15 seconds, potentially reducing healthcare resource utilization associated with intravenous dosing [2] - The safety profile of subcutaneous administration is comparable to intravenous administration, with less than 2% incidence of systemic injection or infusion-related reactions [3] Group 3: Clinical and Regulatory Context - Lecanemab, the active ingredient in Leqembi, is a humanized monoclonal antibody targeting both protofibrils and amyloid plaques, which are key factors in Alzheimer's disease [4][6] - Lecanemab is already approved in 53 countries and is under regulatory review in 7 additional countries, with various dosing regimens established [7] - Ongoing clinical studies, such as the AHEAD 3-45 study, are exploring the efficacy of lecanemab in preclinical Alzheimer's disease [9] Group 4: Collaboration and Company Background - BioArctic has a long-term collaboration with Eisai for the development and commercialization of Alzheimer's disease treatments, including lecanemab [10] - BioArctic retains rights to commercialize lecanemab in the Nordic region and has no development costs associated with it, receiving milestone payments and royalties on global sales [10] - BioArctic focuses on innovative treatments for neurodegenerative diseases and has a broad research portfolio, including projects targeting Parkinson's disease and ALS [11]