Regulatory Decision Summary for Rebinyn
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.
Product type:
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What was the purpose of this submission?
The purpose of this New Drug Submission was to seek marketing authorization for the use of Rebinyn in adults and children with hemophilia B. The approved indications are:
Rebinyn (Coagulation Factor IX (Recombinant), pegylated) is 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
- 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
Why was the decision issued?
The safety, efficacy and pharmacokinetics of Rebinyn were evaluated in five multicenter, open-label clinical trials, including a total of 105 male previous treated patients (PTPs) with hemophilia B (≤2% FIX activity).
The benefits of Rebinyn have been showed in routine prophylaxis, control of bleeding episodes, and perioperative management. The safety profile derived from the clinical trials was generally considered acceptable. Rebinyn was generally well tolerated in the study population.
Taking into account the potential risks of Rebinyn, the current availability of Factor IX products with extended half-life, and the currently available experience with other pegylated products, it was concluded that the routine prophylaxis indication for Rebinyn should be limited to patients aged 18 years and older. The short-term use (on-demand treatment of bleeding episodes and perioperative management) was considered acceptable for all age of patients.
The Risk Management Plan was reviewed and considered acceptable for use in Canada.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| REBINYN | 02470268 | NOVO NORDISK CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 1000 UNIT / VIAL |
| REBINYN | 02470276 | NOVO NORDISK CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 2000 UNIT / VIAL |
| REBINYN | 02470187 | NOVO NORDISK CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 500 UNIT / VIAL |