Regulatory Decision Summary for COSENTYX SA
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 add a new indication for Cosentyx (secukinumab) for the treatment of adult patients with active ankylosing spondylitis (AS).
Why was the decision issued?
The safety and efficacy of Cosentyx were assessed in two randomized, double-blind, placebo-controlled studies in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy. The results obtained from these clinical trials showed that the treatment with Cosentyx was superior to placebo in improving the signs and symptoms of the AS. No overall differences were observed in the safety of Cosentyx in ankylosing spondylitis population and in the previous authorized populations. Therefore, the overall Benefit/Risk of Cosentyx for the treatment of ankylosing spondylitis is considered favourable.
The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4.
In order to ensure that benefit continues to outweigh any risk, Health Canada has required several post-approval activities to be carried out as well as a Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations