Society and culture
Legal status
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.
Recombinant human factor VII, while initially looking promising in intracerebral hemorrhage, failed to show benefit following further study and is no longer recommended.In people with hemophilia type A and B who have a deficiency of factors VIII and IX, these two factors are administered for controlling bleeding or as prophylaxis medication before starting surgeries. However, in some cases they subsequently develop neutralizing antibodies, called inhibitors, against the drug. These inhibitors often increase over time and inhibit the action of coagulation in the  body. Recombinant factor VIIa, which is an activated form of factor VII, bypasses factors VIII and IX and causes coagulation without the need for factors VIII and IX. It cant be given without inhibitor. It is important for some patients to shift to proper blood factors according to their inhibitor titer. Other indications include use for patients with acquired hemophilia, people born with a deficiency of factor VII, and people with Glanzmanns thrombasthenia. Pharmacology
Mechanism of action
This treatment results in activation of the extrinsic pathway of blood coagulation. Coagulation factor VIIa (recombinant)-jncw
Coagulation factor VIIa (recombinant)-jncw (Sevenfact) is expressed in the mammary gland of genetically engineered rabbits and secreted into the rabbits milk. During purification and processing of the milk, FVII is converted into activated FVII (FVIIa).