Recombinant factor VIIa also known as eptacog alfa (INN), and sold under the brand name NovoSeven among others, is a form of blood factor VII that has been manufactured via recombinant technology. It is administered intravenously (IV). Medical uses
NovoSeven is approved for use in the United States and is indicated for the treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.NovoSeven RT is approved in the United States and is indicated for the treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmanns thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets and for the treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.Sevenfact [coagulation factor VIIa (recombinant)-jncw] is approved for use in the United States and is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents twelve years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).As of 2012, recombinant factor VIIa is not supported by the evidence for treating most cases of major bleeding. There is a significant risk of arterial thrombosis with its use and thus, other than in those with factor VII deficiency, it should only be given in clinical trials.
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NovoSeven was approved for use in the United States in March 1999, and indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX. It was approved in October 2006, and indicated for the treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.NovoSevenRT was approved for use in the United States in May 2008, as a room temperature stable formulation. In January 2010, the label was updated to include a black box warning on serious thrombotic adverse events associated with the use of NovoSeven RT outside labeled indications.In April 2020, coagulation factor VIIa (recombinant)-jncw (Sevenfact) was approved for use in the United States.On 19 May 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cevenfacta, intended for the treatment of bleeding episodes. The applicant for this medicinal product is Laboratoire français du Fractionnement et des Biotechnologies (LFB). The active substance of Cevenfacta is eptacog beta (activated), a blood coagulation factor (ATC code: B02BD08). Eptacog beta is almost identical to, and functions like, coagulation factor VII. It activates factor X, which starts the clotting process and thereby provides control of the bleeding.