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Eptacog beta (activated) is a recombinant human Coagulation Factor VIIa (rFVIIa) produced using Laboratoire Français du Fractionnement et des Biotechnologies' (LFB) proprietary rPRO™ technology, which involves expression in the milk of transgenic rabbits. It is a bypassing 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. The drug functions by binding to tissue factor at the site of vascular injury, forming a complex that activates Coagulation Factor X to Xa and Factor IX to IXa. This initiates the coagulation cascade and leads to thrombin generation and fibrin clot formation, bypassing the need for functional Factors VIII or IX. It received FDA approval in April 2020 and is commercialized in the U.S. by HEMA Biologics.
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