FDA approves Novoeight (NovoNordisk) for Haemophilia A

Novo Nordisk announced that the FDA has approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, Novoeight (turoctocog alfa). The FDA approved Novoeight for use in adults and children with Haemophilia A for: . Control and prevention of bleeding . Perioperative management . Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Novoeight has been studied in the GUARDIAN clinical programme; one of the largest and most comprehensive pre-registration clinical trial programmes in the field of Haemophilia therapy with more than 210 severe Haemophilia A patients. In the completed trials Novoeight demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development, and all patients in the surgery trial were treated effectively. Novoeight will be launched with the newly introduced prefilled device, MixPro.

Awaiting the expiration of existing patents, Novo Nordisk plans to launch in the U.S. Novoeight shortly after April 2015.