BRIEF—EU approval for LFB's Cevenfacta/Sevenfact

LFB, a French biopharma that develops, manufactures and markets plasma-derived products and recombinant proteins, has announced that its Cevenfacta (eptacog beta) has been granted marketing authorization in Europe.

Cevenfacta, the first new bypassing agent in more than 20 years, is indicated in adults and adolescents for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures, in certain hemophilia patients.

Denis Delval, LFB’s chairman and chief executive, said: “We are very pleased with the approval of Cevenfacta by the European Medicines Agency, which provides a new treatment option for hemophilia 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.”

This comes after the US Food and Drug Administration approved Sevenfact, which is the same drug’s brand name in the USA, in April 2020, for the treatment of bleeding episodes in adults and adolescents with hemophilia A or B with inhibitors. It was also approved in this indication in Mexico in June of this year. The marketing authorization file has also been submitted to the UK authorities and the file is currently under review.