Posted by Michael Wonder on 01 Jun 2017
Novo Nordisk receives US FDA approval of Rebinyn (nonacog beta pegol; N9-GP)
31 May 2017 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Rebinyn for the treatment of adults and children with haemophilia B.
Rebinyn is the brand name for nonacog beta pegol; N9-GP. Rebinyn is indicated for on-demand treatment and control of bleeding episodes and the peri-operative management of bleeding around the time of surgery in adults and children with haemophilia B.
The efficacy and safety evaluation was based on 115 patients across the four paradigm clinical trials, and the approval follows the Blood Products Advisory Committee meeting held 4 April 2017.
