LFB today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) 2061 for SEVENFACT, a new recombinant coagulation Factor VIIa [coagulation factor VIIa (recombinant)-jncw], for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with Hemophilia A or B with inhibitors (neutralizing antibodies). An exclusive license for the commercialization of the product in the USA and Canada has been granted to HEMA Biologics, a joint venture between LFB and US WorldMeds.

Denis Delval LFB’s Chairman and Chief Executive Officer, stated: “We are very pleased with the FDA approval of SEVENFACT® which provides a new treatment option for hemophilia patients. This approval is a validation of an innovative LFB technology. We will now work towards SEVENFACT registration in Europe and other core countries, in order to offer this therapeutic option to patients.”

Hemophilia A or B is a congenital bleeding disorder caused by a dysfunction or deficiency of Coagulation Factor (F) VIII or IX, respectively.