On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
This is the third approval for the anti-FXIIa mAb, following January 2025 approvals by Australia’s Therapeutic Goods Administration (TGA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Andembry® was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for funding on Australia’s Pharmaceutical Benefits Scheme (PBS) at its November 2024 meeting.
Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug (previously referred to as CSL312) accepted in December 2023. According to CSL, Andembry® is also under review by regulatory agencies in Japan, Switzerland and Canada.