European Commission has granted marketing authorisation for Novo Nordisk’s Refixia for the treatment of adolescents and adults with haemophilia B.
The company explained that Refixia is the brand name for nonacog beta pegol; N9-GP. Refixia is indicated for prophylaxis, on-demand treatment of bleeding and surgical procedures in adolescent (>12 years of age) and adult patients with haemophilia B (congenital factor IX deficiency). The efficacy and safety evaluation was based on 115 patients across the five paradigm clinical trials, and the marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), provided 24 March 2017.
“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.”
Novo Nordisk expects to launch Refixia in the first European countries in the fourth quarter of 2017. The authorisation covers all 28 European Union member states.