Posted by Michael Wonder on 17 Jun 2025
US FDA approves CSL's Andembry (garadacimab-gxii), the only prophylactic hereditary angioedema treatment targeting factor XIIa with once monthly dosing for all patients from the start
16 June 2025 - Once monthly dosing reduced HAE attacks by a median of more than 99% and a least squares mean of 89.2%, compared to placebo.
CSL today announced the US FDA approved Andembry (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema in adult and paediatric patients aged 12 years and older.
