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Head-to-head pharmacokinetic study demonstrated greater factor IX activity with Rebinyn® versus rFIXFc in people with hemophilia B

PLAINSBORO, N.J., May 21, 2018 /PRNewswire/ -- A new head-to-head pharmacokinetic study showed that adults with hemophilia B who received a single dose (50 IU/kg) of Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated] achieved high factor IX activity for longer than those treated with rFIXFc [Coagulation Factor IX (Recombinant), Fc Fusion Protein]. Factor IX activity observed with Rebinyn® was 4.39 times greater than rFIXFc and increased over time, providing six-times greater activity at seven days than rFIXFc at the same dose. These pharmacokinetic findings from the paradigm™7 trial were presented today at the WFH 2018 World Congress in Glasgow, UK.1

"Until now, there has been no direct pharmacokinetic comparison of these two extended half-life therapies," said Mindy Simpson, M.D., a hematologist/oncologist at Rush University Medical Center in Chicago and an investigator in the paradigm™7 trial comparing Rebinyn® and rFIXFc. "The study results provide clinicians a better understanding of the pharmacokinetic differences between these hemophilia B treatments."

Thirty minutes after administration, factor IX levels were twice as high in adults treated with Rebinyn® versus those who received rFIXFc. Rebinyn® also prolonged factor IX activity in the body much longer than rFIXFc, achieving an average half-life of 103.2 hours vs. 84.9 hours, respectively.1

"Rebinyn® is a prime example of our deep, ongoing commitment to the rare disease community," said Pia D' Urbano, Corporate Vice President, Biopharmaceuticals, Novo Nordisk Inc. "We are proud to offer people living with hemophilia B an extended half-life treatment that can help them reach and maintain high factor IX levels for a long period of time."

About hemophilia B
Hemophilia is a chronic, inherited bleeding disorder that primarily affects males. People with hemophilia B have congenital factor IX deficiency with missing or reduced levels of clotting factor IX, a key protein needed for proper blood clotting.2

In the U.S., it is estimated that 5,000 of 21,000 people with hemophilia have been diagnosed with hemophilia B. Of these, approximately 27% have severe hemophilia, 37% have moderate hemophilia and 35% have mild hemophilia, defined by FIX activity levels.3

About the paradigm™7 trial
Paradigm™7 was a multicenter, open-label, randomized, crossover, pharmacokinetic trial in previously treated adult males with congenital hemophilia B (factor IX activity ≤2%), conducted in three countries (U.S., Germany, Switzerland). Patients received single injections (50 IU/kg) of Rebinyn® and rFIXFc with ≥21 days between doses. The primary endpoint was dose-normalized area under the factor IX activity-time curve.

About Rebinyn®
Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated] is an extended half-life factor IX molecule for on demand treatment of bleeding and perioperative management in patients with hemophilia B. It is not indicated for routine prophylaxis or immune tolerance induction.4 The review of Rebinyn® was based on the paradigm™ program; in these completed phase 3 trials, 115 previously treated patients had a total of more than 8,800 exposure days for up to 2.7 years of treatment with Rebinyn®.

For more information about Rebinyn®, visit www.Rebinyn.com

Indications and Usage

What is Rebinyn® Coagulation Factor IX (Recombinant), GlycoPEGylated?
Rebinyn® is an injectable medicine used to replace clotting Factor IX that is missing in patients with hemophilia B. Rebinyn® is used to treat and control bleeding in people with hemophilia B. Your healthcare provider may give you Rebinyn® when you have surgery. Rebinyn® is not used for routine prophylaxis or for immune tolerance therapy.

Important Safety Information

What is the most important information I need to know about Rebinyn®?

  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing Rebinyn®.

Who should not use Rebinyn®?
Do not use Rebinyn® if you:

  • are allergic to Factor IX or any of the other ingredients of Rebinyn®.
  • are allergic to hamster proteins.

What should I tell my health care provider before using Rebinyn®?
Tell your health care provider if you:

  • have or have had any medical conditions.
  • take any medicines, including non-prescription medicines and dietary supplements.
  • are nursing, pregnant, or plan to become pregnant.
  • have been told you have inhibitors to Factor IX.

Important Safety Information (cont'd)

How should I use Rebinyn®?

  • Rebinyn® is given as an infusion into the vein.
  • Call your healthcare provider right away if your bleeding does not stop after taking Rebinyn®.
  • Do not stop using Rebinyn® without consulting your healthcare provider.

What are the possible side effects of Rebinyn®?

  • Common side effects include swelling, pain, rash or redness at the location of the infusion, and itching.
  • Call your healthcare provider right away or get emergency treatment right away if you get any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face.
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • Animals given repeat doses of Rebinyn® showed Polyethylene Glycol (PEG) inside cells lining blood vessels in the choroid plexus, which makes the fluid that cushions the brain. The potential human implications of these animal tests are unknown.

Please click here for Prescribing Information.

About Novo Nordisk
Novo Nordisk, a global healthcare company, has been committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for success is to stay focused, think long term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

References

  1. Escuriola-Ettingshausen C, Hegemann I, Simpson M, et al. A head-to-head pharmacokinetic comparison of N9-GP and rFIXFc in patients with haemophilia B. Presented at the WFH 2018 World Congress, Glasgow, UK, May 20-24, 2018.
  2. Srivastava A, Brewer AK, Mauser-Bunschoten EP et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1-47.
  3. Community counts: The HTC Population Profile. Centers for Disease Control and Prevention website. https://www.cdc.gov/ncbddd/hemophilia/communitycounts/documents/htc-population-profile-report-5-rev2_508compliant.pdf. Accessed May 4, 2018.
  4. Rebinyn® Prescribing Information. May 31, 2017. https://www.rebinynpro.com

Rebinyn® is a registered trademark of Novo Nordisk Health Care AG.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.

© 2018 Novo Nordisk   All rights reserved.   US18REB00015   May 2018

SOURCE Novo Nordisk

For further information: Media: Marisa Sharkey, +1 609-786-4784, mzsx@novonordisk.com; Investors: Peter Hugreffe Ankersen, +45 3075 9085, phak@novonordisk.com; Hanna Ögren, +45 3079 8519, haoe@novonordisk.com; Anders Mikkelsen, +45 3079 4461, armk@novonordisk.com; Christina Kjær, +45 3079 3009, cnje@novonordisk.com
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