Biotest has developed a fibrinogen concentrate purified from human plasma (BT-524), which is marketed and approved by the EMA and FDA as Pufibry and Fesilty.
Fibrinogen is a plasmatic coagulation protein (Factor I) produced in the liver and is not only essential, but is also one of the most important factors of the clotting cascade. Upon conversion into fibrin, it takes on a crucial role in clot formation and haemostasis. In case of fibrinogen deficiency, the blood’s ability to form a clot is impaired, leading to a greatly increased risk of critical bleeding and additionally to a delay in bleeding cessation.
In the case of severe congenital fibrinogen deficiency, patients' ability to produce sufficient levels of functional fibrinogen is impaired or absent. These patients require frequent injections of fibrinogen concentrate. In acquired fibrinogen deficiency, patients lose endogenous fibrinogen, which can lead to uncontrolled bleeding. A frequent cause is high blood loss during complex surgery but also severe traumatic injuries. In this case fibrinogen must be administered intravenously to stop the bleeding by increasing fibrinogen above the critical level.
Biotest’s fibrinogen concentrate has been clinically tested in a multinational phase I/III study in patients with congenital fibrinogen deficiency. For acquired fibrinogen deficiency, Biotest has recently completed a Phase III clinical trial (AdFirst: Adjusted Fibrinogen Replacement Strategy) in several European countries, enrolling patients undergoing planned major spinal or abdominal surgery. Based on the results of the two successful clinical trials, Biotest has applied to the EMA for approval of fibrinogen concentrate for the treatment of patients with congenital and acquired fibrinogen deficiency. The FDA granted the approval for Fesilty to treat patients with congenital Fibrinogen deficiency.