Novo Nordisk is seeking regulatory approval for a recombinant coagulation factor VIII, turoctocog alfa (NN7008), intended for prevention and treatment of bleeding in people with haemophilia A, in the Europe and the US.
The filing for marketing authorisation was based on the results from guardian1 and guardian3 trials, which were concluded in 2011 and demonstrated efficacy in preventing and treating bleeds without any development of inhibitors.
Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said, "Turoctocog alfa represents a new treatment alternative for people with haemophilia A and is one of the first important outcomes of the haemophilia research strategy we embarked upon in 2006."
The company expects to file applications in other countries for regulatory approval of turoctocog alfa, which is based on the advanced protein and purification technology, in the coming months.