Novo Nordisk announced that the FDA has approved its Biologics License Application (BLA) for Novoeight (turoctocog alfa).
Novoeight is a recombinant coagulation factor VIII indicated for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Novoeight has been studied in the Guardian clinical program that enrolled more than 210 patients with severe hemophilia A. Novoeight demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development.
Novoeight will be launched with the new prefilled device, MixPro, shortly after April 2015.
For more information call (800) 727-6500 or visit Novordisk-US.com.