Grifols has received US Food and Drug Administration (FDA) approval for its fibrinogen concentrate FESILTY (fibrinogen, human-chmt) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia. The product is expected to be available in the U.S. during the first half of 2026.

Developed and produced by Biotest, a Grifols Group company, FESILTY will be commercialized in the U.S. by Grifols. CFD is a rare inherited condition present from birth, caused by genetic mutations that affect fibrinogen production or function. Fibrinogen, produced in the liver, is essential for blood clotting and wound healing, and low levels can make it difficult to control bleeding during acute events.

Current treatment options for low fibrinogen levels include fresh frozen plasma, cryoprecipitate or fibrinogen concentrate. Fresh frozen plasma and cryoprecipitate contain additional proteins not needed for fibrinogen replacement and often require large-volume infusions. FESILTY, by contrast, is highly purified with a precise fibrinogen dose, allowing for rapid and predictable restoration of fibrinogen levels—critical in acute bleeding scenarios.

Roland Wandeler, president of Grifols Biopharma, said: “With the approval of FESILTY, we are excited to be able to provide U.S. health care providers and patients with CFD a safe, effective and reliable treatment for acute bleeding episodes – when every minute counts. This is another meaningful step forward in our mission to bring more medicines to more patients around the world.”

A apA Prospective, Open-label, Phase 1/3 Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen DeficiencyFDproval was based on results from the clinical study.

FESILTY is manufactured at the Biotest Next Level production facility in Dreieich, Germany. The U.S. is the second country to approve the fibrinogen concentrate, following Germany, where it is marketed as Prufibry. Additional European approvals are expected in 2026.