1 April 2020 - The U.S. FDA today 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 haemophilia A or B with inhibitors (neutralising antibodies).
Sevenfact contains an active ingredient expressed in genetically engineered rabbits.
The safety and efficacy of Sevenfact were determined using data from a clinical study that evaluated 27 patients with haemophilia A or B with inhibitors, which included treatment of 465 mild or moderate, and three severe bleeding episodes.