Novo Nordisk announced the launch of Rebinyn (coagulation factor IX [recombinant], GlycoPEGylated) for the treatment of hemophilia B. The product is intended to treat and control bleeding in children and adults with hemophilia B, and can be used to manage bleeding during surgery.

Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate with an extended half-life, was approved by the Food and Drug Administration (FDA) in May 2017

The approval was based on findings from Phase 3 studies where a single dose (40 IU/kg) in adults elevated factor activity above baseline levels by 94% and sustained average factor levels of 17% one week post-dose. Adult patients also achieved an average half-life of 83 hours after a single infusion of Rebinyn. 

In the paradigm clinical trial program, Rebinyn treated 98% of patient bleeds with 1 or 2 doses in the on-demand arm of the adolescent and adult trial. In addition, a single preoperative dose demonstrated a 100% success rate in bleeding control during surgery among adolescent and adult study patients. 

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Rebinyn is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B. It is available as single-use vials containing nominally 500 IU, 1000 IU or 2000 IU of Factor IX potency with a diluent and vial adapter.

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