Grifols’ Biotest has received its first regulatory approval for a fibrinogen concentrate, marking a significant step in expanding treatment options for congenital and acquired fibrinogen deficiency. Germany has granted marketing authorisation for the therapy, which will be commercialised as Prufibry in the country and is expected to reach patients by the end of 2025.

The medicine was reviewed through a decentralised procedure with Austria and Spain scheduled to follow in 2026. It has been cleared for adults, children and adolescents with congenital fibrinogen deficiency (CFD) or acquired fibrinogen deficiency (AFD) linked to bleeding during surgery or trauma. CFD is a rare inherited disorder caused by mutations affecting the production or function of fibrinogen, whereas AFD typically manifests during major blood loss in surgical or trauma settings.

Biotest developed and manufactures the product at its facility in Dreieich, Germany. The concentrate provides a defined dose of fibrinogen, allowing physicians to replace the missing protein quickly and predictably. Existing treatment approaches such as fresh frozen plasma and cryoprecipitate often require large infusion volumes because they include additional proteins not needed for fibrinogen replacement.

Fibrinogen is essential for clot formation and wound healing. When levels fall too low, patients face a high risk of uncontrolled bleeding. Grifols said the new concentrate adds a targeted option to its bleeding management portfolio.

Jörg Schüttrumpf, chief scientific innovation officer at Grifols and chief executive of Biotest AG, said: “With this approval, patients in Germany will have access to a safe, effective and reliable treatment to help prevent and control major bleeding, including in life-threatening cases, particularly in surgical and trauma scenarios.” He added that the product could give physicians confidence to “act decisively and swiftly when faced with a bleeding patient – especially in situations where every second counts.”

The company emphasised the viral safety and purity achieved through its manufacturing processes, noting the importance of ensuring sustainable use of plasma-derived materials.

Beyond Europe, Grifols has submitted a biologic license application in the US, with a regulatory decision expected by the end of the year.

The approval is supported by a clinical programme that includes two recent publications. In June 2025, eClinicalMedicine published results from AdFirst, a Phase 3 trial in AFD showing the fibrinogen concentrate met its primary endpoint and was non-inferior to standard care in reducing intraoperative blood loss, with a favourable safety profile. A second study in Thrombosis and Haemostasis in October 2025 reported positive outcomes in CFD, demonstrating predictable pharmacokinetics and hemostatic efficacy across adult and paediatric groups.

With regulatory momentum building in Europe and a US decision pending, Grifols and Biotest plan to expand access as countries complete their assessments of the therapy.