相关临床试验
14
0 进行中
药物批准
14
批准总数
监管机构
1
监管机构数
成立时间
1946
已完成
10
71.4%
招募中
1
7.1%
终止
3
21.4%
- Grifols' fibrinogen concentrate BT524 met its primary endpoint in the Phase III AdFIrst trial, demonstrating non-inferiority to standard of care for treating bleeding in acquired fibrinogen deficiency during major surgery. - The study showed BT524 reduced intraoperative blood loss by 279 mL compared to fresh frozen plasma/cryoprecipitate, with significantly lower thromboembolic events. - BT524 is on track for European launch later this year and U.S. approval in early 2026, potentially transforming hemorrhage management in surgical settings. - The positive results were published in The Lancet's eClinicalMedicine and presented at the International Society on Thrombosis and Haemostasis Congress.
- Biotest AG achieved €726.2 million in sales for 2024, a 6.1% increase driven primarily by strong performance of Intratect and Yimmugo, with EBIT reaching €94.5 million at the upper end of forecast range. - The FDA approved Yimmugo in June 2024 and certified Biotest's production facility, enabling the company to secure a long-term distribution agreement with Kedrion Biopharma expected to generate over $1 billion in the next seven years. - Biotest successfully completed the AdFirst Phase III trial and submitted marketing authorization applications for its new fibrinogen preparation in key European markets and to the FDA, with approval decisions expected by the end of 2025.
- Biotest has submitted a Biologics License Application (BLA) to the FDA for its Fibrinogen product, addressing acquired fibrinogen deficiency. - The application includes treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency, expanding its potential use. - Clinical data supports the efficacy and safety of Biotest's Fibrinogen, offering advantages over current treatments like fresh frozen plasma. - The FDA is expected to make a decision by the end of 2025, following a similar application submitted in Europe in October 2024.
- Biotest's fibrinogen concentrate BT524 met its primary endpoint in the AdFIrst phase 3 trial, demonstrating non-inferiority to standard care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency. - The treatment showed a 291 mL reduction in mean blood loss compared to standard care (1,444 mL vs 1,735 mL) while maintaining an excellent safety profile during major spinal or abdominal surgery. - Regulatory approval processes are set to begin in Q4 2024 in Europe and the United States, targeting a global market with an estimated potential of USD 800 million. - If approved, BT524 would become the first fibrinogen concentrate specifically indicated for acquired fibrinogen deficiency in the United States.
