On 24 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved CSL’s Andembry® (garadacimab) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.
This makes the UK the second jurisdiction to approve Andembry® (previously referred to as CSL312), following world first Australian approval in late January 2025. Andembry® also received a positive opinion in December 2024 from the European Medicine Agency’s CHMP and is currently under review by the US FDA, with CSL’s Biologics Licence Application (BLA) for Andembry® accepted in December 2023.