Novo Nordisk Launches Rebinyn® in the United States for People with Hemophilia B

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Feb 08, 2018, 09:05 ET

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 control bleeding in adults and children with hemophilia B. It can be used to treat bleeds when they occur and to help manage bleeding during surgery. Rebinyn^® is not for routine prophylaxis (regular infusions to prevent bleeding) or for immune tolerance induction (treatment of inhibitors) in patients with hemophilia B.¹

"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^®?

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.

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 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

Rebinyn^® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; May 2017.
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 February 7, 2018.
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 at: https://www.ncbi.nlm.nih.gov/books/NBK1495/. Accessed February 7, 2018.