On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older with C1 esterase inhibitor deficiency or dysfunction. The regulatory approval for registration in Australia is the first in the world for Andembry®.
It 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® (previously referred to as CSL312) accepted in December 2023.