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