Novo Nordisk files for regulatory approval of turoctocog alfa for haemophilia A in the US and EU

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

“We are very excited about having reached this goal. 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,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Turoctocog alfa demonstrates Novo Nordisk’s commitment to the wider haemophilia community as the new alternative in factor VIII treatment. Based on the most advanced protein and purification technology, the product has been designed to expand reliability, safety and portability for 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 3 trials included previously treated adults and children with severe haemophilia A and demonstrated efficacy in preventing and treating bleeds with no development of inhibitors.

In the coming months, applications for regulatory approval in other countries will be submitted.

About haemophilia A

Haemophilia is a chronic, inherited bleeding disorder that affects males. People with haemophilia A are either missing or have a malfunctioning factor VIII protein, which is essential for proper blood clotting. People with haemophilia A have a tendency to bleed longer than most, or to bleed internally, because they are missing this clotting factor. To manage the disease and stop bleeding, people with haemophilia A must replace the missing factor VIII protein, which is accomplished by intravenous infusion of the clotting factor.

Globally, it is estimated that 500,000 people have haemophilia A. The disease is severely under-diagnosed in developing countries.

About turoctocog alfa

Turoctocog alfa (NN7008) is a third-generation recombinant coagulation factor VIII in development for the prevention and treatment of people with haemophilia A, and could provide a reliable and portable treatment option. The product is manufactured using the latest recombinant technology.