Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab)

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. have launched the anti-amyloid beta monoclonal antibody "LEQEMBI" in Austria and will launch it in Germany, marking the first launches in the EU after receiving European Commission approval in April 2025 for treating early Alzheimer's disease [1][2]. Company Overview - Eisai serves as the lead for the development and regulatory submissions of lecanemab globally, with both Eisai and Biogen co-commercializing and co-promoting the product [6][16]. - Biogen, founded in 1978, is a leading biotechnology company focused on innovative science to deliver new medicines and create value for shareholders [20]. Product Details - LEQEMBI targets both amyloid plaque and protofibrils, addressing a significant unmet need for new treatment options that slow the progression of Alzheimer's disease [3][9]. - The Clarity AD clinical trial demonstrated that treatment with lecanemab reduced clinical decline on the Clinical Dementia Rating – Sum of Boxes (CDR-SB) by 31% at 18 months compared to placebo [4][12]. Clinical Trial Insights - The Clarity AD trial involved 1,795 patients with early Alzheimer's disease, with 1,521 in the EU indicated population (ApoE ε4 non-carriers or heterozygotes) [12]. - The most common adverse reactions in the EU indicated population included infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%) [5][12]. Regulatory and Market Context - LEQEMBI has been approved in 48 countries and is under regulatory review in 10 countries, with a supplemental Biologics License Application for intravenous maintenance dosing approved in the U.S. [13][12]. - The controlled access program is in place in Austria and Germany to ensure patient safety and appropriate use of the medicine [2][8].