CHMP recommends Cevenfacta to control bleeding episodes in patients with congenital haemophilia.
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation 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). Cevenfacta will be available as a powder and solvent for solution for injection. 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. Because factor VII acts directly on factor X, independently from factors VIII and IX, Cevenfacta can be used to restore haemostasis in their absence or in the presence of inhibitors.
The benefit of Cevenfacta is its ability to effectively control bleeding episodes, as observed in a phase III, multicentre, open-label trial. The most common side effects are dizziness, headache, infusion site discomfort and haematoma, increased body temperature, post-procedural haematoma and infusion-related reactions.
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