Grifols has launched Fesilty in the USA, making the fibrinogen concentrate available for the treatment of acute bleeding episodes in children and adults with congenital fibrinogen deficiency.

The plasma-derived medicine received approval from the FDA in December 2025 and is indicated for patients with congenital fibrinogen deficiency, including hypo- or afibrinogenaemia, but not dysfibrinogenaemia.

Congenital fibrinogen deficiency is a rare inherited disorder in which the body produces insufficient or abnormal fibrinogen, a protein essential for blood clotting. Patients can experience severe bleeding episodes that require rapid replacement of fibrinogen to restore normal clotting function.

According to Grifols, Fesilty is supplied as a purified fibrinogen concentrate that can be reconstituted quickly and stored at room temperature at the point of care, offering an alternative to blood products such as cryoprecipitate or fresh frozen plasma.

guy young, director of the Hemostasis and Thrombosis Center at the University of Southern California’s Keck School of Medicine, said: “The availability of an additional fibrinogen concentrate in the U.S. is a meaningful development for clinicians caring for patients with congenital fibrinogen deficiency during acute bleeding events.”

He added: “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 crossmatching.”

The launch expands Grifols’ portfolio of plasma-derived therapies for bleeding disorders and provides another treatment option for healthcare professionals managing patients with this rare condition.

The FDA approval was supported by data from a prospective Phase 1/Phase 3 clinical study evaluating the pharmacokinetics, efficacy and safety of the therapy in patients with congenital fibrinogen deficiency. Results published in peer-reviewed journals reported favourable haemostatic efficacy and safety in the treatment of acute bleeding episodes in both adults and children.

roland wandeler, president of Grifols Biopharma, said: “With FESILTY now available in the U.S., health care providers have a safe, effective and reliable treatment for acute bleeding episodes in patients with CFD.”

The US launch marks the transition of Fesilty from an approved medicine to one that is commercially available, expanding therapeutic options for patients with congenital fibrinogen deficiency who require prompt fibrinogen replacement during bleeding events.