CSL Receives Approval in Japan for ANDEMBRY® (garadacimab) Subcutaneous (S.C.) Injection 200mg Pens, a Novel Human Anti-Activated Factor XII Monoclonal Antibody for the Prevention of Acute Attacks of Hereditary Angioedema (HAE)

Core Viewpoint - CSL Behring K.K. has received approval from Japan's Ministry of Health, Labour and Welfare for ANDEMBRY® (garadacimab) Subcutaneous Injection 200mg Pens, marking a significant advancement in the management of hereditary angioedema (HAE) [1][3] Product Overview - ANDEMBRY is the first fully human monoclonal antibody in Japan designed to inhibit activated Factor XII (Factor XIIa), which is crucial in the angioedema attack process [2] - The product is approved for the prevention of acute attacks of HAE and is the first pre-filled pen for once-monthly subcutaneous administration for long-term prophylaxis [1][6] Clinical Significance - The approval is based on the efficacy and safety data from the pivotal international Phase 3 VANGUARD trial, which included HAE patients from Japan [4][6] - HAE is a rare, chronic, debilitating genetic disorder affecting approximately 430 diagnosed patients in Japan, with a global prevalence estimated at 1 in 50,000 people [3][4] Company Commitment - CSL has a 40-year commitment to HAE research and treatment optimization, with ANDEMBRY being the first approved recombinant monoclonal antibody developed entirely by CSL [3][5] - The company emphasizes its dedication to improving the lives of those with HAE, having supported this community for over four decades [6][9] Approval Timeline - ANDEMBRY has also received approvals in Australia, the United Kingdom, and the European Union, indicating a broad acceptance of the product in multiple markets [1][7]