Regulatory Decision Summary for Entyvio
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?
Entyvio (vedolizumab) is authorized for the treatment of adult patients with moderate to severe ulcerative colitis or Crohns disease who have had lack of response to conventional and/or other treatments. It is administered as an intravenous infusion of 300 mg vedolizumab at Week 0, Week 2, Week 6, and every 8 weeks thereafter.
The purpose of this submission was to seek approval for a subcutaneous (SC) route of administration of Entyvio (vedolizumab) for maintenance treatment of ulcerative colitis (UC) in patients who demonstrated clinical response to initial vedolizumab treatment administered by intravenous (IV) infusion.
Why was the decision issued?
- Authorization was based on clinical trial data from a Phase 3 trial that compared the efficacy and safety of three types of maintenance treatment for ulcerative colitis (UC): 108 mg subcutaneous (SC) Entyvio (vedolizumab) every 2 weeks; 300 mg intravenous (IV) Entyvio (vedolizumab) every 8 weeks; placebo.
- After 52 weeks of treatment, patients treated with Entyvio SC dosing were significantly more likely than placebo-treated patients to achieve clinical remission, muscosal healing, and durable clinical response.
- Exposure-response analyses demonstrated that the rates of key efficacy endpoints including clinical remission and mucosal healing were consistent across matched exposures between the SC and IV maintenance regimens.
- There were no clinically relevant differences in safety profile between SC Entyvio and the established safety profile for IV Entyvio for maintenance treatment, with the exception of injection site reactions occurring in 7.6% of patients having SC injections.
- After evaluation of the submitted data package, Health Canada authorized the optional SC maintenance dosing of Entyvio (vedolizumab). The recommended dose regimen of SC Entyvio as a maintenance treatment, following at least two intravenous infusions, is 108 mg administered by SC injection once every 2 weeks. The first SC dose should replace the next scheduled intravenous dose and every 2 weeks thereafter.
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 |
|---|---|---|---|
| ENTYVIO | 02497875 | TAKEDA CANADA INC | VEDOLIZUMAB 108 MG / 0.68 ML |
| ENTYVIO | 02497867 | TAKEDA CANADA INC | VEDOLIZUMAB 108 MG / 0.68 ML |