Grifols (MCE: GRF, NASDAQ: GRFS) announced the US launch of FESILTY, a fibrinogen concentrate approved by the Food and Drug Administration for treating acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency.

The FDA approved FESILTY in December for patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia, but not for dysfibrinogenemia. The treatment addresses a rare inherited condition caused by genetic mutations that impair fibrinogen production or function.

FESILTY provides a purified fibrinogen concentrate that enables rapid restoration of fibrinogen levels during bleeding events. The product can be stored at room temperature and reconstituted in approximately three minutes, according to the company's press release.

"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 Guy Young, director of the Hemostasis and Thrombosis Center at University of Southern California's Keck School of Medicine.

FDA approval was based on evidence from a clinical study examining the drug's pharmacokinetic properties, efficacy and safety. Results from this study were published in Thrombosis and Haemostasis in October 2025 and Thrombosis Research in March 2026.

The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis and deep vein thrombosis. One patient died due to extradural hematoma four weeks after administration. Common adverse reactions in clinical studies included pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, and headache.

Barcelona-based Grifols produces plasma-derived medicines and operates more than 400 donation centers across North America, Europe, Africa, the Middle East, and China.