CSL receives approval in Japan for Andembry (garadacimab) subcutaneous injection 200mg pens, a novel human anti-activated Factor XII monoclonal antibody for the prevention of acute attacks of hereditary angioedema (HAE)

CSL announced that it has received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Andembry (garadacimab) subcutaneous injection 200mg Pens. The product is approved for the prevention of acute attacks of hereditary angioedema (HAE) and is the first pre-filled pen presentation for once-monthly subcutaneous administration for long-term prophylaxis of HAE. The approval in Japan follows additional recent approvals received in Australia, the United Kingdom, and the European Union.

Andembry is the first fully human monoclonal antibody in Japan designed to inhibit activated Factor XII (Factor XIIa), which initiates the cascade of events leading to angioedema at various sites of the body.

Bill Mezzanotte MD, Executive Vice President, Head of R&D at CSL, said: “Andembry represents a major advancement in the management of hereditary angioedema, offering people living with this life-threatening condition long-term disease control through a patient-centric and convenient administration method. As CSL’s first approved recombinant monoclonal antibody discovered and developed entirely by CSL, Andembry underscores our more than 40-year commitment to HAE research and treatment optimization. This milestone is the result of decades of dedication, and we extend our gratitude to the colleagues, physicians and patients who made this possible for HAE patients and CSL.”

(Source: CSL)