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Rebinyn FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 31, 2022.

FDA Approved: Yes (First approved May 31, 2017)
Brand name: Rebinyn
Generic name: coagulation factor IX (recombinant), glycopegylated
Dosage form: Injection
Company: Novo Nordisk
Treatment for: Hemophilia B

Rebinyn (coagulation factor IX (recombinant), glycoPEGylated) is an extended-half-life, recombinant DNA-derived coagulation factor IX concentrate used in the management of bleeding episodes in patients with hemophilia B.

  • Rebinyn is indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for:
    • on-demand treatment and control of bleeding episodes
    • perioperative management of bleeding
    • routine prophylaxis to reduce the frequency of bleeding episodes.
  • Rebinyn is administered via intravenous infusion.
  • Warnings and precautions associated with Rebinyn include hypersensitivity reactions, development of factor IX inhibitors, thromboembolic complications, and nephrotic syndrome.
  • Frequently reported adverse reactions in previously treated patients (PTPs) and previously untreated patients (PUPs) include itching and injection site reactions. Additional frequently reported adverse reactions in PUPs include rash, factor IX inhibition, hypersensitivity, and anaphylactic reaction.


Development timeline for Rebinyn

Jul 29, 2022Approval Novo Nordisk Receives FDA Approval for Rebinyn (coagulation factor ix) for Routine Prophylaxis to Prevent Bleeding in Hemophilia B
May 31, 2017Approval FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B
Apr  4, 2017FDA Advisory Committee Discusses Biologics License Application (BLA) for Nonacog Beta Pegol for the Treatment of People with Hemophilia B

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.