Grifols has begun marketing its new fibrinogen concentrate Fesilty in the United States, indicated for the treatment of acute bleeding in adult and pediatric patients with congenital fibrinogen deficiency (CFD), which includes hypo- or afibrinogenemia, although it is not approved for cases of dysfibrinogenemia.
CFD is a rare hereditary disorder that affects the production or function of fibrinogen, a plasma protein synthesized in the liver and essential for blood clotting and wound healing processes, as the company details this Monday in a statement.
When the body has low levels of fibrinogen, it is difficult to adequately control bleeding, especially if it is acute. Fesilty is a highly purified concentrate that contains a precise amount of this protein, allowing for rapid and predictable replenishment of fibrinogen levels.
At room temperature and with quick preparation
This new concentrate can be stored at room temperature and comes with a complete kit that facilitates its reconstitution in approximately 3 minutes.
Until now, available options (such as cryoprecipitates and frozen plasma) also provided unnecessary proteins for fibrinogen replacement, usually required high volumes to achieve adequate concentrations, and needed more time for both preparation and administration.
The director of the Hemostasis and Thrombosis Center at the Keck School of Medicine of the University of Southern California, Guy Young, has pointed out that specific fibrinogen replacement has growing support, and that purified concentrates "allow for predictable dosing, can be administered quickly, and do not require cross-matching tests."
For his part, the president of Grifols Biopharma, Roland Wandeler, has emphasized that healthcare professionals now have a "safe, effective, and reliable treatment for acute bleeding episodes in patients with CFD, when every minute counts."