Novo Nordisk says it expects to launch its long-acting haemophilia B drug Refixia in the European Union in the fourth quarter of this year after receiving a green light from regulators.
The European Commission has now approved the drug’s use for prophylaxis, on-demand treatment of bleeding and surgical procedures in adults and adolescents with the condition.
Refixia (nonacog beta pegol; N9-GP) is glycopegylated recombinant factor molecule that has a significantly improved pharmacokinetic profile and a five-times longer half-life than standard forms of the blood-clotting drug.
In the Phase III trials, once-weekly administration of Refixia maintained factor IX activity levels above 15 percent, reduced the median annualised bleeding rate to 1.0 and showed a potential to prevent bleeds in target joints. Furthermore, patients reported an improvement in quality of life during the trial. The most common side effects are nausea, pruritus, fatigue and injection site reactions.
“We are excited about the approval of Refixia in the EU, and we consider it an important expansion of the treatment options for patients with haemophilia B,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
“The strong clinical profile of Refixia provides haemophilia B patients with better protection against bleeds, even into damaged joints, and an overall improved quality of life.”