Regulatory Decision Summary for Enbrel
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?
This Supplement to a New Drug Submission was filed to obtain market authorization of Enbrel for the treatment of severe plaque psoriasis in pediatric patients ages 4 to 17 who are candidates for systemic therapy or phototherapy.
Why was the decision issued?
The efficacy and safety of Enbrel (etanercept) were evaluated in a Phase 3 randomized double-blind placebo-controlled clinical trial conducted in pediatric patients 4 to 17 years of age. The results showed that treatment with Enbrel was effective in clearing skin lesions and reducing symptoms related to severe plaque psoriasis in pediatric patients 4 to 17 years of age.
The recommended dose of Enbrel is 0.8 mg/kg per week up to a maximum of 50 mg per week as a subcutaneous injection.
The safety profile of Enbrel in the pediatric population with plaque psoriasis is considered comparable to that in authorized pediatric indications. However, data for children 4 to 6 years of age with plaque psoriasis is limited. No new safety signals were identified. Therefore, the Benefit/Risk of Enbrel for the indication authorized above is considered favorable.
In order to ensure that the benefit continues to outweigh the risk after authorization, Health Canada has required that several standard post-approval activities be carried out, along with a Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations