Regulatory Decision Summary for SIMPONI
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 Supplement to a New Drug Submission (SNDS) is to add a new indication for SIMPONI (golimumab) for the treatment of adult patients with severe active non-radiographic axial spondyloarthritis (nr-ax SpA).
Why was the decision issued?
The safety and efficacy of Simponi 50 mg were assessed in one randomized, double-blind, placebo-controlled study in adult patients with severe active nr-ax SPA with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence and who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). The results obtained from this clinical trial showed that the treatment with Simponi 50 mg was superior to placebo in improving the signs and symptoms of the nr-ax SPA. No overall differences were observed in the safety of Simponi 50 mg in nr-ax SPA population and in the previous authorized populations. Therefore, the overall Benefit/Risk of Simponi for the treatment of nr-ax SPA is considered favourable.
The recommended dose is 50 mg given as a subcutaneous injection once a month, on the same date each month.
In order to ensure that benefit continues to outweigh any risk, Health Canada has required 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.