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Eptacog beta is a recombinant form of human coagulation factor VIIa (rFVIIa) produced in the mammary glands of genetically engineered rabbits using the rPRO technology. Developed by Hema Biologics in partnership with LFB, it is a 'bypass agent' indicated for the treatment and control of bleeding episodes in adults and adolescents (12 years and older) with hemophilia A or B who have developed inhibitors (antibodies) against factor VIII or IX. The drug works by binding to tissue factor at the site of vascular injury, which activates factor X and factor IX, leading to a burst of thrombin generation and the formation of a stable fibrin clot, effectively bypassing the need for the deficient factors in the intrinsic pathway. It was approved by the U.S. FDA in April 2020.
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