Novo Nordisk said today it got the Biologics License Application approval from the US Food and Drug Administration (FDA) 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 perioperative management of bleeding around the time of surgery in adults and children with haemophilia B.
Mads Krogsgaard Thomsen, chief science officer of Novo Nordisk, said: “We are excited about the approval of Rebinyn in the US, and we consider it an important expansion of the treatment options for patients with haemophilia B. We are confident that Rebinyn will become an important tool for physicians to help patients manage their bleeds.”