Novo Nordisk announced that the Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Rebinyn (coagulation factor IX [recombinant], GlycoPEGylated) for the treatment of patients with hemophilia B

Rebinyn is specifically intended for on-demand treatment and control of bleeding episodes, and for the perioperative management of bleeding in children and adults with hemophilia B. The safety and efficacy of Rebinyn was studied in 115 patients across four multicenter, non-controlled paradigm trials (n=105). Across the clinical program, 597 bleeding episodes were reported in previously treated patients. Minor/moderate bleeds were treated with Rebinyn 40 IU/kg and major bleeds were treated with 80 IU/kg.

The overall success rate (“excellent” or “good”) for the treatment of bleeding episodes was 93.2%. One injection was needed to treat a bleeding episode in 87% of patients, and two injections were needed to treat 10% of patients. In the on-demand treatment arm, 143 bleeding episodes were reported for which the overall success rate was 95.1%. 

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Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate, temporarily replaces the missing coagulation Factor IX in these patients as it is necessary for effective hemostasis. Rebinyn is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.

Rebinyn will be supplied as single-use vials containing nominally 500 IU, 1000 IU or 2000 IU of Factor IX potency with a diluent and vial adapter. It is anticipated to be available in the first half of 2018.

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