LFB announces the approval of CEVENFACTA® in the European Union
LFB announces the approval of CEVENFACTA® (eptacog beta) in the European Union.
This new recombinant coagulation Factor VIIa is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in adults and adolescents (12 years of age or older) with haemophilia A or B with inhibitors.
Denis Delval, LFB’s Chairman and Chief Executive Officer, stated: “We are very pleased with the approval of CEVENFACTA® by the EMA, which provides a new treatment option for haemophilia patients with inhibitors in the European Union. This approval is a validation of our innovative LFB technology and the acknowledgement of LFB’s deep commitment to patients.”
Dr. Patrick Delavault, MD, LFB’s Executive Vice President Scientific, Medical and Regulatory Affairs, stated: “We need to keep in mind constantly what a bleeding event, even a single bleeding event, means to a haemophilia patient with inhibitors and to his family. This novel treatment alternative is a significative opportunity to improve patients’ lives”.