On 26 February 2025, CSL announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Andembry® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and certain paediatric patients.
Switzerland is the fifth jurisdiction to approve Andembry®, and all other approvals have occurred this year. Australia was first to approve Andembry® in January 2025, closely followed by the UK (January 2025), EU (February 2025) and Japan (February 2025).
Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug accepted in December 2023. According to CSL, Andembry® is also under review in Canada.