Today, in Canada, Novo Nordisk announced the launch and availability of Rebinyn® (Coagulation Factor IX (Recombinant), pegylated), an anti-hemophilic factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for control and prevention of bleeding episodes and control and prevention of bleeding in the perioperative setting. Rebinyn® is also indicated in patients 18 years and above with hemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.1
Hemophilia is an inherited bleeding disorder affecting the blood's ability to clot. It can affect people from all races and ethnic origins. Hemophilia B is very rare, affecting just 1 in 50,000 people, or about 600 Canadians.2
"Canadians with joint damage caused by hemophilia live with pain and with limited ability to participate in simple, everyday activities like playing sports or being active," says Dr. Jerry Teitel MD, FRCP and Medical Director, St. Michael's Hospital Hemophilia Treatment Centre. "The approval of Rebinyn® offers patients a new, long-acting treatment option that will help to prevent this kind of disability, and that will provide effective control of bleeding when it does occur."
Rebinyn® has a half-life five times longer than standard FIX products and a significantly improved pharmacokinetic (PK) profile.3 For patients, this means less frequent dosing, helping to alleviate the impact of hemophilia B, and improving the quality of life for both them and their families.4
"The Canadian Hemophilia Society advocates for access to the widest possible range of coagulation therapies and welcomes the introduction of Rebinyn® in Canada," said Paul Wilton, the Society's president.
The approval of Rebinyn® was granted based on the results from the paradigm™ clinical trial program, where 115 previously treated children and adults with hemophilia B were treated with Rebinyn®. Rebinyn® was found to be efficacious in routine prophylaxis, treatment of bleeding (breakthrough and on-demand),5 and in prevention of bleeding during surgery in adults and adolescents (>12y).6 The most common adverse reactions (may affect up to 1 in 10 people) were injection site reactions (3.5 per cent) and itching or pruritus (2.6 per cent).7
Patients receiving Rebinyn® in the phase 3 study program, paradigm™, achieved consistently higher FIX activity levels than those previously reported with standard FIX products. Once-weekly administration of 40 IU/kg Rebinyn® for prophylaxis in adults maintained a mean FIX activity trough level of 29 per cent,1 resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.0 and a resolution of majority of target joints.8 Furthermore, these patients reported an improvement in their quality of life during the trial.9
About Rebinyn®
Rebinyn® is a glycopegylated recombinant factor IX (rFIX) administered by intravenous bolus injection. Pegylated products have been approved in hemophilia A10 and other therapeutic areas.11,12 Rebinyn® reduces bleeding frequency and has the potential to prevent further bleeds in target joints with less frequent injections for adult patients on prophylaxis,13 due to a half-life that is five times longer than standard rFIX.14 Rebinyn® has also received regulatory approval in the EU and the United States. Rebinyn® is available through Canadian Blood Services, and therefore, currently not available in Quebec.
About paradigm™
The paradigm™ clinical trial program comprises several trials that studied the safety, efficacy, PK profile and immunogenicity of Rebinyn® in adult and adolescent populations. The use of Rebinyn® for prophylaxis, on-demand treatment of bleeding and surgery was evaluated. In addition, a trial...
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