• The European Commission and the MHRA have approved CSL's Andembry (garadacimab) for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older.
• Andembry, a Factor XIIa-inhibitory monoclonal antibody, offers a novel approach by targeting the initiation of the angioedema cascade with a once-monthly subcutaneous injection.
• Clinical trials, including the VANGUARD trial, demonstrated that Andembry significantly reduced HAE attack rates and achieved attack-free status in a substantial portion of patients.
• The approvals mark a significant advancement in HAE management, providing patients with a convenient, long-term control option, and are based on positive Phase 3 trial results.