Novo Nordisk has filed turoctocog alfa for haemophilia A on both sides of the Atlantic.
Marketing applications have been made to the European Medicines Agency and the US Food and Drug Administration for turoctocog, a third-generation recombinant coagulation factor VIII intended for the prevention and treatment of bleeding in people with haemophilia A. The filings are based upon the results of two studies which involved more than 200 people, "the largest clinical pre-registration trial programme conducted in haemophilia A".
Mads Krogsgaard Thomsen, Novo's chief science officer, said that turoctocog "represents a new treatment alternative...and is one of the first important outcomes of the haemophilia research strategy we embarked upon in 2006". The Danish drugmaker markets NovoSeven (recombinant Factor VIIa), but that haemophilia drug is now off-patent in certain territories.
Novo, which earlier this month discontinued development of another haemophilia treatment vatreptacog alfa, said that "based on the most advanced protein and purification technology", turoctocog has been designed "to expand reliability, safety and portability for people with haemophilia A".
The company added that it will submit applications for regulatory approval in other countries in the coming months.