Grifols Plans to Launch BT524 in Europe by the End of the Year and Expects Approval to Launch in the United States by Early 2026
Grifols has announced positive results from the phase 3 trial of its fibrinogen concentrate BT524, which have been published in the journal «EclinicalMedicine» (a member of «Lancet»), as reported in a press release on Thursday.
The phase 3 study achieved its primary objective, demonstrating that treatment with BT524 «is not inferior to standard treatment with frozen plasma or cryoprecipitate in reducing clinically relevant intraoperative bleeding in patients with acquired fibrinogen deficiency (AFD)» undergoing major or scheduled abdominal surgery.
The launch of BT524 (developed by Biotest, a Grifols company) is scheduled for later this year in Europe and, pending FDA approval, for early 2026 in the United States.
Jörg Schüttrumpf, Grifols’ Chief Scientific Innovation Officer, stated that these results support the potential of BT524 «to be considered in clinically controlled bleeding patients» and added that they hope to complete the regulatory approval processes in Europe and the United States as soon as possible.
The physician and lead study coordinator, Niels Rahe-Meyer.
The study data will be presented as part of three abstracts at the International Society of Thrombosis and Hemostasis (ISCH) 2025 Congress, to be held in Washington DC from June 21 to 25.
Positive Safety Profile of BT524
In the study, the mean intraoperative blood loss was 1381 ml (95% confidence interval [CI], 1187-1574) in the BT524 group and 1660 ml (95% CI 1461-1860) in the frozen fresh plasma/cryoprecipitate group, resulting in a 279 ml difference in blood loss between the study groups.
BT524 «demonstrated a positive safety profile and a lower incidence of thromboembolic events».
The Role of Fibrinogen
Fibrinogen (a plasma protein produced in the liver) is essential in stopping bleeding and clot formation, and AFD is generally associated with uncontrolled larger bleeding, such as in surgical interventions, trauma, or postpartum hemorrhage.
Low fibrinogen levels are insufficient to stop bleeding and are usually treated with fibrinogen sources like cryoprecipitate.
The BT524 Fibrinogen Concentrate trial, known as ADFIRST (Adjusted Fibrinogen Replacement Strategy), was a prospective, actively controlled, multicenter non-inferiority phase trial investigating the efficacy and safety of BT524 in patients with acquired fibrinogen deficiency.
Adfirst data has been presented at conferences before, such as the International Symposium on Intensive Care and Emergencies (Isicem); the Network for the Advancement of Patient Blood, Hemostasis, and Thrombosis (CREMA); and the European Society of Anesthesiology and Intensive Care (ESIC).
Grifols’ experience with fibrinogen-based medications for surgical bleeding control also includes a fibrin sealant launched by the company five years ago.
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Grifols Announces Positive Results for BT524 Phase 3 Trial
Grifols has announced positive results from the phase 3 trial of its fibrinogen concentrate BT524, which have been published in the journal «EclinicalMedicine» (a member of «Lancet»), as reported in a press release on Thursday.
The phase 3 study met its primary endpoint, demonstrating that treatment with BT524 «is non-inferior to standard treatment with frozen plasma or cryoprecipitate or fresh in reducing clinically relevant intraoperative bleeding in patients with acquired fibrinogen deficiency (AFD)» in a major or scheduled abdominal surgical intervention.
The launch of BT524 (developed by Biotest, part of the Grifols group) is planned for the end of this year in Europe and, pending FDA approval, for early 2026 in the United States.
Grifols’ Chief Scientific Innovation Officer, Jörg Schüttrumpf, stated that these results support the potential of BT524 «to be considered in clinically controlled bleeding patients» and added that they expect to complete the regulatory approval processes in Europe and the United States as soon as possible.
The physician and principal study coordinator, Niels Rahe-Meyer.
The study data will be presented as part of three abstracts at the 2025 Congress of the International Society of Thrombosis and Hemostasis (ISCH), which will take place in Washington DC from June 21 to 25.
Positive Safety Profile of BT524
In the study, the mean intraoperative blood loss was 1381 ml (95% confidence interval [CI], 1187-1574) in the BT524 group and 1660 ml (95% CI 1461-1860) in the fresh frozen plasma/cryoprecipitate group, resulting in a 279 ml blood loss difference between the study groups.
BT524 «demonstrated a positive safety profile and a lower incidence of thromboembolic events».
The role of fibrinogen
Fibrinogen (a plasma protein produced in the liver) is essential in stopping bleeding and clot formation, and AFD is generally associated with larger uncontrolled bleeding, such as in surgical interventions, trauma, or postpartum hemorrhage.
Low fibrinogen levels are insufficient to stop bleeding and are typically treated with fibrinogen sources like cryoprecipitate.
The BT524 Fibrinogen Concentrate trial, known as ADFIRST (Adjusted Fibrinogen Replacement Strategy), was a prospective, active-controlled, multicenter non-inferiority phase trial investigating the efficacy and safety of BT524 in patients with acquired fibrinogen deficiency.
Adfirst data has been previously presented at congresses such as the International Symposium on Intensive Care and Emergencies (Isicem); the Network for the Advancement of Patient Blood, Hemostasis, and Thrombosis (crema); and the European Society of Anesthesiology and Intensive Care (ESIC).
Grifols’ experience with fibrinogen-based medications for surgical bleeding control also includes a fibrin sealant launched by the company five years ago.