Grifols, a global healthcare company and leading producer of plasma-derived medicines, announces that its fibrinogen concentrate, FESILTY (fibrinogen, human-chmt), has been approved by the US Food and Drug Administration for the treatment of acute bleeding episodes in paediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia.
Developed and produced by Biotest (a Grifols Group company), FESILTY will be commercialised in the US by Grifols and is expected to be available during the first half of 2026.
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 that is essential for blood clotting and wound healing.
Insufficient fibrinogen levels impede the body’s ability to effectively control bleeding, particularly during acute bleeding events.
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.
Grifols’ fibrinogen concentrate is a highly purified product with a precisely defined amount of fibrinogen, enabling rapid and predictable restoration of fibrinogen levels – an important benefit in critical bleeding events.
“With the approval of FESILTY, we are excited to be able to provide US healthcare 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.”
FDA approval 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,” (NCT02065882).
The product is manufactured at the “Biotest Next Level” production facility in Dreieich, Germany.
The US is the second country to approve this new fibrinogen concentrate. It was first approved in Germany in November where it is being commercialised by Biotest under the brand Prufibry.
Approvals in additional European markets are expected in 2026.