Grifols’ Biotest receives first regulatory approval for its fibrinogen concentrate

Barcelona, Spain, November 13, 2025 - Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), a global healthcare company and leading producer of plasma-derived medicines, today announced that its fibrinogen concentrate has been approved by the German competent authority, the Paul-Ehrlich-Institut, for the treatment of congenital (CFD) and acquired fibrinogen deficiency (AFD).

Germany is the first European country to grant marketing authorization for the company’s fibrinogen concentrate, following a decentralized regulatory procedure with Austria and Spain expected to follow in 2026.

The new fibrinogen concentrate, developed and produced by Biotest (a Grifols Group company), has been approved to treat CFD and AFD caused by bleeding due to surgery or trauma for adults, children and adolescents (0-18 years). CFD is a rare inherited condition present from birth and caused by genetic mutations affecting the production or function of fibrinogen, while AFD typically results from severe bleeding during complex surgical procedures or trauma.  

Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing. When fibrinogen levels are too low, the body cannot effectively stop bleeding.

Treatment options for low fibrinogen levels include fresh frozen plasma, cryoprecipitate or fibrinogen concentrate. Cryoprecipitate and fresh frozen plasma contain other proteins and components that are not essential for fibrinogen replacement and often require infusions of large volumes to achieve adequate fibrinogen levels.

Grifols’ fibrinogen concentrate is a highly purified product with a precisely defined amount of fibrinogen, allowing for a predictable response and a rapid replenishment of fibrinogen, which is important in these critical moments.

“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,” said Dr. Jörg Schüttrumpf, Chief Scientific Innovation Officer at Grifols and CEO of Biotest AG. “It’s a meaningful step forward in our mission to transform care for patients facing critical bleeding risks. We believe this product will give physicians the confidence to act decisively and swiftly when faced with a bleeding patient – especially in situations where every second counts.”

The product, which will be commercialized under the brand Prufibry^® in Germany, is produced in the “Biotest Next Level” production facility in Dreieich, Germany. The state-of-the-art manufacturing process yields a highly purified product with robust viral safety, contributing to a sustainable use of the valuable plasma.

Beyond Europe, Grifols has also submitted a biologic license application for the fibrinogen concentrate in the U.S., with regulatory determination expected by the end of the year.

Strong clinical development program

The results of the clinical trials supporting regulatory approval have been published in leading scientific journals. In June 2025, eClinicalMedicine (The Lancet) published the positive results of AdFIrst, a Phase 3 study¹ evaluating Grifols’ fibrinogen concentrate in patients with AFD. The article highlights that the trial met its primary endpoint, demonstrating non-inferiority to standard of care in reducing intraoperative blood loss, while maintaining an excellent safety profile.

In October 2025, Thrombosis and Haemostasis published the results of a study² evaluating our fibrinogen concentrate in patients with CFD. This research confirmed the therapy’s favorable pharmacokinetic profile, strong hemostatic efficacy and safety in both adult and pediatric patients.