Regulatory Decision Summary for STELARA
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 was to seek market authorization of STELARA for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Why was the decision issued?
The efficacy and safety of STELARA (ustekinumab) were evaluated in a Phase 3, randomized, double blind, placebo-controlled clinical trial conducted in pediatric patients 12 to 17 years of age. The results of this trial showed that treatment with STELARA, compared to placebo, is effective in clearing skin lesions and reducing symptoms related to chronic moderate to severe plaque psoriasis in adolescent patients from 12 to 17 years of age.
The recommended dose of STELARA® is based on body weight: 0.75 mg/kg for patients weighing <60 kg, 45 mg for patients weighing between ≥ 60 kg and ≤ 100 kg, and 90 mg for patients weighing >100 kg. STELARA is administered via subcutaneous injection at Weeks 0 and 4, then every 12 weeks thereafter.
The safety profile of STELARA is this pediatric population is considered comparable to that known in adult patients with the same plaque psoriasis condition. No new safety signals were identified. Therefore, the overall Benefit/Risk of STELARA for the indication authorized above is considered favourable.
In order to ensure that this benefit continues to outweigh any risk after authorization, Health Canada has required several post-approval activities to be carried out and a Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.