FDA approves Novo's Rebinyn for hemophilia B

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) said FDA approved a BLA for Rebinyn nonacog beta pegol (N9-GP, pegylated recombinant human Factor IX, PEG-rFIX) to treat and control bleeding in patients with hemophilia B. Specifically, the therapy is approved for on-demand treatment and control of bleeding episodes and the perioperative management of bleeding around the time of surgery in adults and children. Novo plans to launch the product in 1H18.

In March, EMA’s CHMP recommended approval of an MAA for the product to treat and prevent bleeding in patients ages ≥12 with hemophilia B. The product has Orphan Drug designation in the EU, where it is called Refixia (see BioCentury, April 3)...