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 (CD) who have had lack of response to conventional and/or other treatments. It is administered as an intravenous (IV) infusion of 300 mg vedolizumab at Week 0, Week 2, Week 6, and every 8 weeks thereafter.
The purpose of the submission was to seek approval for a subcutaneous route of administration of Entyvio (vedolizumab) for maintenance treatment of Crohns disease in patients who demonstrated clinical response to induction treatment administered by intravenous infusion of Entyvio.
Why was the decision issued?
Authorization was based on clinical trial data from a randomized, double-blind, placebo-controlled trial SC-3031. Patients (n = 409) with Crohns disease, who achieved clinical response at Week 6 following open-label IV Entyvio induction treatment, received either subcutaneous (SC) Entyvio 108 mg (n = 275) or placebo (n = 134) every 2 weeks for 46 weeks.
At Week 52, significantly higher proportion of patients achieved clinical remission in the SC Entyvio maintenance treatment group compared to the placebo group.
No noticeable changes in the safety profile for SC Entyvio were identified compared to IV Entyvio from the previously established safety profile in CD patients, except for the injection site reaction (3.4%).
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 subcutaneous injection once every 2 weeks. The first subcutaneous dose should be administered in place of 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.