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Approval Alert: CSL’s Andembry® (Garadacimab) Approved in Switzerland

Feb 26, 2025

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.