CSL Behring K.K.  President and Representative Director: Izumi Yoshida)  announced that it launched ANDEMBRY® Subcutaneous Injection 200 mg Pen (garadacimab), a novel human anti-activated Factor XII monoclonal antibody for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) in Japan.

ANDEMBRY® is a novel Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) designed to inhibit activated Factor XII (Factor XIIa), which initiates the cascade of events leading to angioedema at various sites of the body. It is the first prefilled pen formulation for HAE treatment, offering the convenience of once-monthly administration. On February 20, 2025, CSL received manufacturing and marketing approval for ANDEMBRY® from Japan’s Ministry of Health, Labour and Welfare (MHLW), based on efficacy and safety data from the global Phase III "VANGUARD" trial  and its open-label extension study, which included HAE patients, including those from Japan.

Izumi Yoshida, President and Representative Director of CSL Behring K.K., stated:
“We are extremely proud to offer ANDEMBRY® to patients in Japan as a new treatment option for HAE. Featuring a first-in-class mechanism of action and the convenience of a once-monthly pre-filled pen, ANDEMBRY® represents a significant advancement in HAE care. This milestone is the culmination of CSL Behring’s 40 years of dedication to delivering innovative therapies in the HAE field. We are confident that ANDEMBRY® will provide effective long-term prophylaxis of recurrent attacks, reducing the disease burden on patients and enhancing their quality of life (QOL).

With the approval of ANDEMBRY®, CSL has further strengthened its comprehensive portfolio, complementing Berinert® IV and Berinert® SC. This reinforces our long-standing commitment to the HAE community and enhances our ability to meet the evolving needs of patients.