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?
The purpose of this SNDS is to extend the use of Entyvio (vedolizumab) for the treatment of adult patients with moderately to severely active Crohn’s disease.
Why was the decision issued?
The safety and efficacy of Entyvio for the treatment of Crohn‘s disease were evaluated in three clinical trials involving patients who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. Results showed that a greater percentage of participants treated with Entyvio compared to a placebo achieved clinical remission at induction and maintenance phases. No overall differences were observed between the safety of Entyvio in Crohn’s disease population and the other authorized patient populations.
The recommended dose regimen of Entyvio is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Based on the above, Health Canada considers that the overall Benefit/Risk of Entyvio for the treatment of Crohn’s disease is favourable. However, in order to ensure that this benefit continues to outweigh any risk after authorization, Health Canada has required several post-approval activities and a Risk Management Plan to be carried out.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.