Novo Nordisk has 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.

“We’re excited to make this new treatment option available to the hemophilia community,” said Pia D’ Urbano, corporate vice president, Biopharmaceuticals, Novo Nordisk. “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. 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.