Novo Nordisk files for EU approval of new haemophilia B therapy

Novo Nordisk has applied for European regulatory approval of a new long-acting factor IX therapy, nonacog beta pegol, for the treatment of haemophilia B.

A marketing authorisation application has been submitted to the European Medicines Agency for the glycopegylated recombinant factor IX therapy, which offers a significantly improved pharmacokinetic profile.

Clinical trial data has shown that the drug is effective in routine prophylaxis, treatment of bleeding episodes and surgery for adults, adolescents and children, with a five times longer half-life than standard factor IX products.

It has been demonstrated to be reduce annualised bleeding rates (ABRs) and deliver quality of life improvements for patients.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "With its high factor activity level, less frequent dosing and very low ABRs, nonacog beta pegol has the potential to improve the quality of life for both patients and their families."

The company also currently has a treatment for haemophilia A that is in phase III clinical development.