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news.CSL Behring has submitted a biologics license application to the FDA requesting approval to market its human fibrinogen concentrate in the US for the treatment of congenital fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of fibrinogen.
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Fibrinogen, also called Factor I, is a protein needed to form a blood clot. Fibrinogen levels in plasma determine the potential clotting ability and activity in the body. Diminished concentrations of fibrinogen limit the body’s ability to form a clot. A simple blood coagulation test is needed to determine fibrinogen levels and confirm a diagnosis.
Robert Lefebvre, vice president and general manager of US commercial operations at CSL Behring, said: “We look forward to making this new therapy available in the US upon the FDA approval, and fulfilling a significant unmet medical need for patients with congenital fibrinogen deficiency.”