FDA approves Grifols’ Fesilty for rare bleeding disorder

Barcelona, Spain-based Grifols (MCE: GRF) announced that its fibrinogen concentrate, Fesilty (fibrinogen, human-chmt), has been approved by the US Food and Drug Administration (FDA) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia.

Developed and produced by Biotest (a Grifols Group company), Fesilty will be commercialized in the USA by Grifols and is expected to be available during the first half of 2026. Grifols recently gained a first European approval for the product in Germany.