Regulatory Decision Summary for Tremfya
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?
This submission was for the purpose of seeking authorization of Tremfya (guselkumab) for the treatment of adults with psoriatic arthritis. After evaluation of the submitted data package, Health Canada authorized Tremfya for the indication of treatment of adults with psoriatic arthritis, used alone or in combination with conventional disease modifying anti-rheumatic drugs (DMARDs).
Why was the decision issued?
Efficacy of Tremfya in patients with psoriatic arthritis (PsA) was assessed in two Phase 3, placebo-controlled, randomized clinical trials. Adult patients with active PsA received either placebo or Tremfya for 24 weeks. In both Phase 3 trials, patients treated with Tremfya were significantly more likely to achieve a reduction in symptoms of PsA compared to placebo. In patients that also had moderate to severe plaque psoriasis, there was a treatment benefit with Tremfya over placebo.
The safety profile was evaluated based on two pivotal trials and one supportive trial. The most common adverse reactions were upper respiratory tract infections, which is consistent with the established profile for Tremfya in patients with plaque psoriasis. Patients with PsA also had increased incidence of elevated liver enzymes compared to placebo, which is a new finding that had not been seen in patients with plaque psoriasis treated with Tremfya. This information has been added to the labelling for Tremfya.
The recommended dose of Tremfya for adult patients with psoriatic arthritis is 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks (Q8W) thereafter.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.