Seeks approval for turoctocog alfa shortly after vatreptacog alfa pulled
Novo Nordisk has filed its first marketing applications for turoctocog alfa, a new recombinant factor VIII product for haemophilia A, in the EU and US.
The company describes turoctocog alfa (NN7008) as a "third-generation" coagulation factor that should provide a "reliable and portable option" for prevention and treatment of bleeding in haemophilia A patients.
If approved, the new drug will enter a fairly crowded market, with several recombinant factor VIII products on the market including Baxter's Advate, Bayer's Kogenate and Pfizer's ReFacto.
The news of the filing is a boost to Novo Nordisk's haemophilia franchise, currently represented by its Factor VIIa product NovoSeven (eptacog alfa), which is starting to experience a sales slowdown as it loses patent protection in some markets.
Last year NovoSeven made $1.4bn in revenues, but Novo has said it expects flat sales this year and analysts predict a decline in 2013.
Novo Nordisk announced a major effort to find new haemophilia treatments in 2006 but suffered a blow last month when it was forced to discontinue development of another recombinant coagulation factor - vatreptacog alfa - after patients in trials developed inhibitory antibodies to the drug.
"Turoctocog alfa … is one of the first important outcomes of the haemophilia research strategy we embarked upon in 2006," commented Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
In the coming months, applications for regulatory approval in other countries will be submitted, said the firm.
The US and EU marketing authorisations for turoctocog alfa are based upon the results of the Guardian 1 and Guardian 3 clinical trials, which were completed last year and included more than 200 people with haemophilia A around the world.
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.
Novo Nordisk has three other clotting factors in late-stage development, including a recombinant factor XIII (NN1841) that has already been submitted for approval, as well as a long-acting recombinant coagulation factor VIII derivative called NN7088 for haemophilia A and NN7999, a long-acting recombinant coagulation factor IX derivative for haemophilia B.