The plasma-based biopharma specialist Grifols has announced the launch of its new fibrinogen concentrate in the US.
The product was approved by the US Food and Drug Administration (FDA) in December last year for the treatment of acute bleeding episodes in paediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia.
CFD is a rare inherited condition caused by genetic mutations that affect fibrinogen production or function.
Fibrinogen is a plasma protein produced in the liver that plays a crucial role in blood clotting and wound healing.
When fibrinogen levels are inadequate, the body struggles to control bleeding effectively, especially during acute bleeding episodes.
FESILTY is not, however, indicated for dysfibrinogenaemia.
Grifols said in its statement that FESILTY will provide healthcare professionals with a new treatment option for acute bleeding in patients with CFD, enabling rapid and predictable restoration of fibrinogen levels.
The highly purified product contains only a precisely defined amount of fibrinogen, in contrast with alternative treatment options such as cryoprecipitate and fresh frozen plasma, which contain additional proteins.
These treatments also often require large infusions to achieve adequate fibrinogen levels and take longer to prepare and administer.
FESILTY can be stored at room temperature at the point of care and is supplied as a complete kit, allowing for rapid reconstitution in approximately three minutes.
"The availability of an additional fibrinogen concentrate in the US is a meaningful development for clinicians caring for patients with congenital fibrinogen deficiency during acute bleeding events," said Dr Guy Young, Director, Hemostasis and Thrombosis Center at University of Southern California's Keck School of Medicine.
Targeted fibrinogen replacement is becoming increasingly well supported and purified concentrates can be especially useful because they allow for predictable dosing, can be administered quickly and do not require cross-matching.
Grifol's launch of the new concentrate will broaden its bleeding management offering and further expand its portfolio of plasma-derived medicines.
"With FESILTY now available in the US, health care providers have a safe, effective and reliable treatment for acute bleeding episodes in patients with CFD — when every minute counts," added Roland Wandeler, President of Grifols Biopharma.
This milestone reflects our continued commitment to bringing more medicines to more patients around the world.
The FDA's approval of FESILTY was based on evidence from a Phase I/III clinical study investigating the efficacy and safety of the therapy, with findings published in October 2025 and March 2026 confirming the therapy's pharmacokinetics, haemostatic efficacy and safety for treatment of acute bleeding episodes in both adults and children with CFD.
