Hemophilia B drug Refixia approved by European Commission

Following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in March, the European Commission has now granted marketing authorization for Refixia (nonacog beta pegol; N9-GP) for the treatment of adolescents and adults with hemophilia B. The authorization covers all 28 European Union member states.

Developed by Danish diabetes care giant Novo Nordisk (NOV: N), Refixia is indicated for prophylaxis, on-demand treatment of bleeding and surgical procedures in adolescent (>12 years of age) and adult patients with hemophilia B (congenital factor IX deficiency). The efficacy and safety evaluation was based on 115 patients across the five paradigm clinical trials.

"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 hemophilia B," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The strong clinical profile of Refixia provides hemophilia B patients with better protection against bleeds, even into damaged joints, and an overall improved quality of life."