FDA Approves Grifols' Fesilty for Congenital Fibrinogen Deficiency Treatment
Key Insights
The FDA has approved Grifols' fibrinogen, human-chmt (search) (Fesilty (search)) for treating acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (search).
The therapy is manufactured by Biotest AG at their advanced facility in Germany and represents the second global approval following Germany's approval in November.
Fesilty (search) is expected to be available in the US market during the first half of 2026, offering a more targeted treatment option compared to existing therapies.
The US Food and Drug Administration has approved Grifols' fibrinogen, human-chmt (search) (Fesilty (search)) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (search) (CFD), including hypo- or afibrinogenemia (search). The approval, announced on December 19, 2025, marks a significant advancement in treating this rare inherited bleeding disorder.
Addressing Critical Medical Need
Congenital fibrinogen deficiency (search) is a rare inherited condition present from birth, caused by genetic mutations affecting the production or function of fibrinogen. Fibrinogen, produced in the liver, 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.
"With the approval of [fibrinogen, human-chmt (search)], 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.
Treatment Landscape and Advantages
Current treatment options for low fibrinogen levels include fresh frozen plasma, cryoprecipitate (search), or fibrinogen concentrate. However, 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.
Fesilty (search) offers a more targeted approach with a defined concentration of high-purity fibrinogen, high level of viral safety, and good solubility. The fibrinogen concentrate alternatives fresh frozen plasma and cryoprecipitate (search) contain variable amounts of fibrinogen and must be thawed prior to treatment, while the defined amount of fibrinogen in Fesilty allows for tailor-made, patient-specific and highly effective therapy.
Manufacturing and Global Expansion
Fesilty (search) is manufactured at the "Biotest Next Level" production facility in Dreieich, Germany, one of the most advanced plasma protein production plants in Europe. The plant combines high efficiency, robust viral safety, and sustainability in the use of plasma as a raw material.
The US represents the second country to approve this new fibrinogen concentrate, following Germany's approval in November, where it is commercialized by Biotest under the brand Prufibry (search). Additional approvals in European markets are expected in 2026.
Clinical Evidence and Safety Profile
The FDA approval was based on evidence from a prospective, open-label, Phase I/III study investigating pharmacokinetic properties of BT524 and efficacy and safety in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiency (search).
The most serious adverse reactions observed with fibrinogen, human-chmt (search) 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.
In clinical studies, the most common adverse reactions that occurred in more than 2% of patients receiving fibrinogen, human-chmt (search) were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
Market Launch Timeline
Grifols expects Fesilty (search) to be available in the US market during the first half of 2026. "This FDA approval marks a major achievement for both Biotest and Grifols," said Dr. Jörg Schüttrumpf, Chief Executive Officer of Biotest AG. "We are proud that our plasma expertise contributes directly to expanding patient access to life-saving fibrinogen therapies in the treatment of critical conditions worldwide."