European Commission approves Refixia for the treatment of adolescents and adults with haemophilia B.- NovoNordisk
Novo Nordisk announced that the European Commission has granted marketing authorisation for Refixia for the treatment of adolescents and adults with haemophilia B. The authorisation covers all 28 European Union member states. Refixia is the brand name for nonacog beta pegol; N9-GP (known as Rebinyn in the US).
Refixia is indicated for prophylaxis, on-demand treatment of bleeding and surgical procedures in adolescent ( more than 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.
Comment: Novo Nordisk expects to launch Refixia in the first European countries in the fourth quarter of 2017.
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