Regulatory Decision Summary for COSENTYX PSA
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 seek market authorization of Cosentyx, used with or without methotrexate, for the treatment of adult patients with active psoriatic arthritis who have not responded adequately to previous disease-modifying anti-rheumatic drug (DMARD) therapy.
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 psoriatic arthritis (PsA) who have had an inadequate response to non-steroidal anti-inflammatory (NSAID), corticosteroid or DMARD 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 PsA. No overall differences were observed in the safety of Cosentyx in psoriatic arthritis population and in the previous authorized populations. Therefore, the overall benefit/risk of Cosentyx for the treatment of psoriatic arthritis 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