MedicalResearch.com Interview with:
Stephanie Seremetis, M.D.
Corporate Vice President and Chief Medical Officer
Biopharmaceuticals at Novo Nordisk
MedicalResearch.com: What is the background for this announcement?
Response: We’re proud and excited to make Rebinyn® (Coagulation Factor IX (Recombinant), GlycoPEGylated) available as a new extended half-life treatment for hemophilia B management.
Rebinyn® is an 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 manage bleeding during surgery. Rebinyn® is not used for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.
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.
Response: Rebinyn® helps patients reach and maintain higher Factor IX levels for a longer period of time. In phase 3 studies, a single dose of Rebinyn® 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®.
Rebinyn® helps patients take control of bleeds with simplified dosing. Unlike other Factor IX products, there is no need to calculate desired Factor IX activity levels when determining the appropriate dose. A single, 40 IU/kg dose is recommended for the on-demand treatment and control of minor or moderate bleeds or 80 IU/kg for major bleeds
MedicalResearch.com: What are the main indications for its use?
Response: Rebinyn®, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Rebinyn® is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.
MedicalResearch.com: What should readers take away from your report?
Rebinyn® is a new treatment option for people with hemophilia B, a rare bleeding disease. With one or two doses, Rebinyn® effectively treats and controls bleeds when they occur. Rebinyn® also provides protection during surgery with a single preoperative dose and additional doses every 1-3 days after major surgery.
MedicalResearch.com: Is there anything else you would like to add?
Response: For people living with a rare disease, it’s important to have multiple treatment options to manage their condition. As no single therapy is right for every patient, Rebinyn® can be an important new treatment option for physicians to successfully help appropriate patients manage their bleeds and maintain bleed control during surgery and procedures.
We’re proud to make Rebinyn® available as a new extended half-life treatment for hemophilia B management. Through our work with patients, we understand the importance of controlling bleeding episodes, which can limit daily activities for both adults and children with hemophilia B. The introduction of Rebinyn® adds to our rich history of making innovative medicines available for people with rare bleeding disorders.
Rebinyn®, Coagulation Factor IX (Recombinant), GlycoPEGylated, is approved by the FDA and available in the US for the treatment of bleeds in hemophilia B patients when they occur and to manage bleeding during surgery.
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