PLAINSBORO, N.J., May 21, 2018 /PRNewswire/ -- A new head-to-head pharmacokinetic study showed that adults with hemophiliaB 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].
"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®?
Who should not use Rebinyn®? Do not use Rebinyn® if you:
What should I tell my health care provider before using Rebinyn®? Tell your health care provider if you:
Important Safety Information (cont'd)
How should I use Rebinyn®?
What are the possible side effects of Rebinyn®?
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.
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
View original content:http://www.prnewswire.com/news-releases/head-to-head-pharmacokinetic-study-demonstrated-greater-factor-ix-activity-with-rebinyn-versus-rfixfc-in-people-with-hemophilia-b-300652136.html
SOURCE Novo Nordisk
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