Posted by Michael Wonder on 02 Aug 2022
Novo Nordisk receives FDA approval for Rebinyn for routine prophylaxis to prevent bleeding in people living with haemophilia B
29 July 2022 - Novo Nordisk announced today that the US FDA has approved the supplemental biologics license application for Rebinyn, coagulation factor IX (recombinant), GlycoPEGylated, a recombinant DNA derived coagulation factor IX concentrate, for use in adults and children with haemophilia B (congenital factor IX deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes.
The safety and efficacy of Renbinyn was evaluated in five multi-centre, non-controlled, open-label trials in on-demand treatment of bleeding episodes, peri-operative management of major and minor surgery, and routine prophylaxis or pharmacokinetic evaluation in 115 previously treated patients with haemophilia B.
