Coagulation factor VIIa to treat hemophiliaMay 9, 2020
The US FDA has granted approval to coagulation factor VIIa (recombinant)-jncw (Sevenfact) 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.
The drug 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 hemophilia A or B with inhibitors, which included treatment of 465 mild or moderate, and three severe bleeding episodes.
The study assessed the efficacy of treatment 12 hours after the initial dose was given. The proportion of mild or moderate bleeding episodes treated successfully both with the lower dose of 75mcg/kg and higher dose of 225 mcg/kg was approximately 86%.