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FDA Approves Rebinyn

FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B

PLAINSBORO, N.J., May 31, 2017 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

Hemophilia B is a chronic and inherited bleeding disorder that affects approximately 5,000 people in the U.S.1 People with hemophilia B have deficient blood clotting factor IX activity that results in prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs.2

Rebinyn® is the brand name for nonacog beta pegol, N9-GP. Rebinyn® is indicated for on-demand treatment and control of bleeding episodes, and the perioperative management of bleeding in adults and children with hemophilia B. Rebinyn® is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B. The efficacy and safety evaluation was based on 115 patients across the four paradigmTM clinical trials, and the approval follows the Blood Products Advisory Committee meeting held on April 4, 2017.3

"We would like to thank the patients who participated in the clinical studies that led to this decision. Thanks to their commitment, we are able to continue to provide new medicines for people with hemophilia," said Bill Breitenbach, Vice President, Biopharmaceuticals Portfolio, Novo Nordisk. "We are committed to the hemophilia community and will continue on our path to bring this new extended half-life treatment to patients who need it."

Novo Nordisk expects to launch Rebinyn® in the U.S. in the first half of 2018.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

References

  1. Community Counts: The HTC Population Profile. Available at: https://www.cdc.gov/ncbddd/hemophilia/communitycounts/documents/htc-population-profile-report-5-rev2_508compliant.pdf. Accessed May 31, 2017.
  2. Konkle BA, Josephson NC, Nakaya Fletcher S. Hemophilia B. 2000 Oct 2 [Updated 2014 Jun 5]. In: Pagon RA, Adam MP, Ardinger HH, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2017. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1495/.
  3. REBINYN® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; May 2017. Novo Nordisk is a registered trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk

Posted: May 2017

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