Hemophilia drug from genetically-engineered rabbits approved by FDA

The US Food and Drug Administration on Wednesday approved Sevenfact (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).

The FDA granted approval of Sevenfact to France-based LFB Group (Laboratoire Francais du Fractionnement et des Biotechnologies). Sevenfact contains an active ingredient expressed in genetically-engineered rabbits.

“Today’s approval provides another treatment option for the control of bleeding episodes in adults and adolescents with hemophilia who have developed inhibitors,” Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER)