Posted by Michael Wonder on 07 Jun 2017
Refixia (nonacog beta pegol; N9-GP) approved in the EU
6 June 2017 - Novo Nordisk today 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. 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 CHMP, under the EMA, provided 24 March 2017.
