Regulatory Decision Summary for Cosentyx
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 submission is to extend the authorised adult plaque psoriasis indication for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 to less than 18 years of age who are candidates for systemic therapy or phototherapy.
Based on the information provided in the submission, the recommended pediatric indication is for the treatment of severe plaque psoriasis in pediatric patients 12 to less than 18 years of age who are candidates for systemic therapy or phototherapy and have a body weight ≥50 kg.
A Notice of Compliance (NOC) was recommended and issued.
Why was the decision issued?
The safety and efficacy of Cosentyx were assessed in a randomized, double-blind, placebo and etanercept-controlled study in 162 pediatric patients aged 6 to less than 18 years with severe plaque psoriasis (PsO).
The benefits of Cosentyx were demonstrated in adolescents with severe PsO. Secukinumab-treated patients received either a low- or a high-dose regimen. The primary objective of the trial was met: both secukinumab doses (low and high) were superior to placebo with respect to the co-primary efficacy endpoint, Psoriasis Area Sensitivity Index (PASI) 75 and Investigators Global Assessment (IGA) mod 2011 0 or 1 responses at Week 1, in the target patient population. The key secondary endpoint PASI 90 response at Week 12 was also met, supporting the primary efficacy results.
Overall, based on the evidence provided, the safety profile of Cosentyx in pediatric patients is generally consistent with that previously established for adults with the exception of an increased rate of reported infection events (overall and serious) and an increased rate of neutropenia events (mostly Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 and/or 2) in pediatric patients. These differences have been adequately communicated in the recommended product monograph and will continue to be monitored as important identified risks post-market as set out in the Cosentyx Risk Management Plan.
The benefit/risk profile of Cosentyx in the target pediatric population (severe PsO, 12 to less than 18 years of age, and body weight ≥50 kg) is favourable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.