Australian biotechnology company CSL (ASX:CSL; USOTC:CSLLY) announced on Thursday that it has received approval from the European Commission for ANDEMBRY (garadacimab), the first and only once-monthly treatment targeting factor XIIa to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

The company says that ANDEMBRY inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body. ANDEMBRY comes with a patient-centric pre-filled pen (auto-injector) enabling subcutaneous self-injection.

The approval of ANDEMBRY was based on efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study. Detailed results from the VANGUARD trial were published in The Lancet in April 2023 and the primary results of the ongoing open-label extension study were published in Allergy in October 2024.

CSL Behring will make ANDEMBRY available for eligible patients upon completion of access and reimbursement negotiations.

ANDEMBRY's centralised marketing authorisation is valid in all European Union member states and in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. The product is currently under review by regulatory agencies in the United States, Japan, Switzerland and Canada.