FDA Approves Fibrinogen, Human-chmt (Fesilty) for Congenital Fibrinogen Deficiency

The US Food and Drug Administration has approved Grifols’ 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.1

According to a December 19, 2025, press release from the Company, fibrinogen, human-chmt will be commercialized in the US by Grifols and is expected to be available during the first half of 2026.1

“With the approval of [fibrinogen, human-chmt], 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,” Roland Wandeler, President of Grifols Biopharma, said in a statement.1 “This is another meaningful step forward in our mission to bring more medicines to more patients around the world.”

CFD is a rare inherited condition present from birth and caused by genetic mutations affecting the production or function of fibrinogen. Produced in the liver, fibrinogen is a plasma protein essential for blood clotting and wound healing. Without sufficient fibrinogen levels, the body cannot effectively control bleeding, particularly during acute bleeding events.1

Treatment options for low fibrinogen levels include fresh frozen plasma, cryoprecipitate or fibrinogen concentrate. Cryoprecipitate and fresh frozen plasma include additional proteins and components that are not necessary for fibrinogen replacement and often require infusions of large volumes to achieve adequate fibrinogen levels.1

Fibrinogen, human-chmt is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. It is manufactured at the “Biotest Next Level” production facility in Dreieich, Germany. The US is the second country to approve this new fibrinogen concentrate, the first being Germany in November, where it is commercialized by Biotest under the brand Prufibry. Approvals in additional European markets are expected in 2026.1,2

Its approval in the US was based on evidence from the clinical study “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.”1

The most serious adverse reactions observed with fibrinogen, human-chmt were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of fibrinogen, human-chmt.1

In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving fibrinogen, human-chmt were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.1

As described in the press release, Grifols expects the product to be available during the first half of 2026.1

References.

1. Grifols. Grifols receives US FDA approval for new fibrinogen concentrate, FESILTYTM (fibrinogen, human-chmt). 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

2. Grifols. Grifols’ Biotest receives first regulatory approval for its fibrinogen concentrate. November 13, 2025. Accessed December 19, 2025. https://www.grifols.com/en/view-news/-/news/grifols-biotest-receives-first-regulatory-approval-for-its-fibrinogen-concentrate