On 20 February 2025, CSL announced that its Andembry® (garadacimab) has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in subcutaneous 200mg injection pens for the prevention of acute attacks of hereditary angioedema (HAE).
This approval makes Japan the fourth jurisdiction to approve Andembry® (previously referred to as CSL312). Australia was the first to approve Andembry® globally in January 2025, closely followed by the UK (January 2025) and the EU (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 by regulatory agencies in Switzerland and Canada.