Regulatory Decision Summary for RIXUBIS
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The approved indication of Rixubis in Canada is for control of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia B. This submission proposes to add a pediatric age indication and to provide efficacy data for the perioperative management of patients with hemophilia B.
Why was the decision issued?
The efficacy and safety of Rixubis was demonstrated in a phase 2/3 prospective trial in previously treated children with hemophilia B (<12 years of age) and a phase 3 trial on the perioperative management of patients with hemophilia B. Rixubis was well tolerated in these target populations. Overall, the benefits of Rixubis outweigh the risks in pediatric patients with hemophilia B and in the perioperative management of patients with hemophilia B.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.