FDA approves fibrinogen, human-chmt for acute bleeding in congenital fibrinogen deficiency

On Decmeber 19, 2025, Grifols announced that the FDA has approved fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia. The plasma-derived fibrinogen concentrate was developed and produced by Biotest, a Grifols Group company, and will be commercialized in the United States by Grifols, with availability expected in the first half of 2026.

Congenital fibrinogen deficiency is a rare inherited bleeding disorder present from birth and caused by genetic mutations that impair the production or function of fibrinogen. Fibrinogen, a plasma protein produced in the liver, plays a critical role in blood clot formation and wound healing. When fibrinogen levels are insufficient, patients face an increased risk of uncontrolled bleeding, particularly during acute bleeding events or following trauma or surgery.

Addressing limitations of existing treatment options

Historically, treatment options for low fibrinogen levels have included fresh frozen plasma, cryoprecipitate, or fibrinogen concentrates. However, fresh frozen plasma and cryoprecipitate contain additional plasma proteins that are not required for fibrinogen replacement and often necessitate the infusion of large volumes to achieve adequate fibrinogen levels. These limitations can be especially challenging in acute or critical care settings, where rapid correction of fibrinogen levels is essential.

According to Grifols, fibrinogen, human-chmt is a highly purified fibrinogen concentrate with a precisely defined fibrinogen content. This allows for rapid and predictable restoration of fibrinogen levels, which the company emphasized as an important benefit during time-sensitive bleeding emergencies.

“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,” said Roland Wandeler, President of Grifols Biopharma. “This is another meaningful step forward in our mission to bring more medicines to more patients around the world.”

Clinical evidence supporting FDA approval

FDA approval of fibrinogen, human-chmt was supported by data from the clinical study titled “A Prospective, Open-label, Phase I/III Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen Deficiency” (NCT02065882).1 The study evaluated the pharmacokinetics, efficacy, and safety of the fibrinogen concentrate in patients with CFD, providing the evidence base for regulatory clearance in the United States.

The product is manufactured at the “Biotest Next Level” production facility in Dreieich, Germany. The United States is the second country to approve this fibrinogen concentrate; it was first approved in Germany in November, where it is marketed by Biotest under the brand name Prufibry®. Grifols noted that approvals in additional European markets are expected in 2026.

Safety considerations and prescribing information

Fibrinogen, human-chmt is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia, but it is not indicated for dysfibrinogenemia. The therapy is contraindicated in patients with severe hypersensitivity reactions, including anaphylaxis, to the product or its components.

Warnings and precautions include the risk of hypersensitivity reactions and thrombotic events, which have occurred in patients receiving the therapy. As a plasma-derived product, fibrinogen, human-chmt also carries a potential risk of transmitting infectious agents, including viruses and, theoretically, the agents responsible for variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease.

In clinical studies, the most serious adverse reactions reported included thrombotic events such as portal vein thrombosis and deep vein thrombosis. The most common adverse reactions occurring in more than 2% of patients included pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, increased fibrin D-dimer levels, headache, and vomiting.

With FDA approval now in place, Grifols positions fibrinogen, human-chmt as a new option for U.S. clinicians managing acute bleeding in patients with this rare but serious inherited disorder.

Reference:

Grifols receives US FDA approval for new fibrinogen concentrate, FESILTY^TM (fibrinogen, human-chmt). Grifols. Press release. December 19, 2025. Accessed December 19, 2025. https://www.grifols.com/en/view-news/-/news/grifols-receives-us-fda-approval-for-new-fibrinogen-concentrate-fesiltytm-fibrinogen-human-chmt