LFB announces FDA approval for Sevenfact, a new recombinant coagulation factor VIIIA for for the treatment of Hemophilia A or B with inhibitors.

LFB announced that the 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. 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 (requiring no further treatment for the bleeding episode, no administration of blood products and no increase in pain beyond 12 hours from initial dose) was approximately 86%. The study also included three severe bleeding episodes that were treated successfully with the higher dose.. Another study evaluated the safety and pharmacokinetics of three escalating doses of Sevenfact in 15 patients with severe hemophilia A or B with or without inhibitors. Results from this study were used to select the two doses, 75mcg/kg and 225 mcg/kg, that were evaluated in the study described above.