CSL’s Andembry approved in Japan
Japan's Ministry of Health, Labor and Welfare (MHLW) has granted manufacturing and marketing approval for Andembry (garadacimab) subcutaneous (SC) injection 200mg pens, developed by Australia’s CSL Limited (ASX: CSL) and to be marketed by its CSL Behring unit.
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 UK 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.
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