Biotest's Fibrinogen Phase III Trial Results Announced

Biotest AG has announced the positive results of its Phase III trial for fibrinogen concentrate BT524, published in eClinicalMedicine. The study, part of the AdFIrst trial, showed BT524 to be non-inferior to standard care in treating bleeding due to acquired fibrinogen deficiency (AFD). Data revealed a significant reduction in intraoperative blood loss and fewer thromboembolic events compared to standard treatments. BT524 is expected to launch in Europe by the end of 2025 and in the U.S. in early 2026, pending FDA approval. Fibrinogen plays a crucial role in blood clotting and wound healing, especially vital during major surgeries. Key presentations of the trial's results will occur at the International Society on Thrombosis and Haemostasis (ISTH) Congress 2025.