Turoctocog alfa (Novo Nordisk) filed for Haemophilia in US and EU

Novo Nordisk announced the submission of the regulatory application for turoctocog alfa (NN7008) to the European Medicines Agency (EMA) and the FDA. Turoctocog alfa is a third-generation recombinant coagulation factor VIII intended for prevention and treatment of bleeding in people with haemophilia A.

The decision to apply for marketing authorisation for turoctocog alfa is based upon the results of the clinical trials GUARDIAN 1 and GUARDIAN 3, which were completed in 2011. More than 200 people with haemophilia A around the world were enrolled, making GUARDIAN the largest clinical pre-registration trial programme conducted in haemophilia A. The phase III trials included previously treated adults and children with severe haemophilia A and demonstrated efficacy in preventing and treating bleeds with no development of inhibitors.