PLAINSBORO, N.J., Feb. 8, 2018 /PRNewswire/ -- Novo Nordisk, a global healthcare company, today announced that Rebinyn®,Coagulation Factor IX (Recombinant), GlycoPEGylated, is now available in the United States for the treatment of hemophilia B.
Rebinyn® is an extended half-life injectable medicine used to treat and
"We're excited to make this new treatment option available to the hemophilia community," said Pia D' Urbano, Corporate Vice President, Biopharmaceuticals, Novo Nordisk Inc. "The introduction of Rebinyn® energizes us to build on our rich legacy of making innovative medicines available for people with rare bleeding disorders."
Hemophilia B is a serious, chronic, inherited bleeding disease that affects about 5,000 people in the U.S.2 People living with hemophilia B have low levels of clotting Factor IX protein in the blood, often resulting in prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs.3 Rebinyn® replaces the clotting Factor IX that people with hemophilia B are missing.
In phase 3 studies, a single dose of Rebinyn® 40 IU/kg in adults was shown to elevate factor activity above baseline levels by 94 percent and sustain average factor levels of 17 percent seven days post-dose. Adults also achieved an 83-hour average half-life after receiving a single infusion of Rebinyn®.1
"Even with significant progress in the treatment of hemophilia B, there is an ongoing need for medicines that help patients reach and maintain high Factor IX levels for a longer period of time," said Guy Young, M.D., Director of the Hemostasis and Thrombosis Program at Children's Hospital Los Angeles, and an investigator in the paradigm™ clinical trial program studying Rebinyn®. "For my patients, an extended half-life treatment that can quickly control a bleed with just one or two doses is an important part of hemophilia B care."
Rebinyn® was evaluated in the paradigm™ clinical trial program. In the on-demand arm of the adolescent and adult clinical trial, Rebinyn® treated 98 percent of patient bleeds with one or two doses. In the surgical clinical study of adolescents and adults, a single preoperative dose of Rebinyn® provided a 100 percent success rate (defined by doctors as excellent or good) in bleeding control during surgery.1 Rebinyn® was approved by the U.S. Food and Drug Administration (FDA) in May 2017.
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:
How should I use Rebinyn®?
What are the possible side effects of Rebinyn®?
Please click here for Prescribing Information.
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.
MixPro® and Rebinyn® are registered trademarks of Novo Nordisk Health Care AG.Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2018 Novo Nordisk All rights reserved. USA17BIO01128 February 2018
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SOURCE Novo Nordisk
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