FDA Approval and Regulatory Updates - The FDA has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing, with a PDUFA action date set for August 31, 2025 [1] - Leqembi is already approved in the US, Japan, China, Great Britain, and other markets, and received a positive opinion from the CHMP of the EMA in November 2024 [2] - Eisai has submitted applications for regulatory approval of lecanemab in several other countries and regions, including the European Union, and a supplemental BLA for less frequent intravenous maintenance dosing was accepted by the FDA in June 2024 [3] Clinical Data and Study Progress - The BLA for Leqembi SC-AI is based on data from the Clarity AD open-label extension (OLE) and modeling of observed data [6] - Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD is ongoing, with full recruitment completed in October 2024 [8] - The Tau NexGen clinical study for Dominantly Inherited AD (DIAD), which includes lecanemab as the backbone anti-amyloid therapy, has been ongoing since January 2022 [12] Product Features and Benefits - Leqembi is the only FDA-approved anti-amyloid therapy that offers the convenience of a subcutaneous injection with at-home administration option [1] - The SC-AI 360 mg weekly maintenance regimen allows patients to receive weekly doses that maintain clinical and biomarker benefits after completing the biweekly IV initiation phase [6] - The SC-AI is expected to be simple and easy to use, reducing the need for hospital or infusion site visits and nursing care for IV administration [10] Collaboration and Commercialization - BioArctic has a long-term collaboration with Eisai since 2005 for the development and commercialization of drugs for Alzheimer's disease, including lecanemab and Leqembi [9] - BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is preparing for commercialization in the Nordics together with Eisai [9] - Eisai is responsible for the clinical development, application for market approval, and commercialization of the products for Alzheimer's disease globally [9] Company Overview - BioArctic is a Swedish research-based biopharma company focusing on innovative treatments for neurodegenerative diseases, including Alzheimer's, Parkinson's, and ALS [13] - The company invented Leqembi, the world's first drug proven to slow the progression of Alzheimer's disease and reduce cognitive impairment in early stages [13] - BioArctic's research portfolio includes several projects utilizing its proprietary BrainTransporter™ technology to enhance the efficacy of treatments by transporting antibodies across the blood-brain barrier [13]
FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US