Regulatory Decision Summary for TALTZ
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 current supplementary new drug submission (SNDS) sought authorization for Taltz (ixekizumab injection) for the treatment of adult patients with active psoriatic arthritis who have responded inadequately to, or are intolerant to one or more disease-modifying antirheumatic drugs (DMARD).
Why was the decision issued?
Taltz is an inhibitor of interleukin-17A (IL-17A), a pro-inflammatory cytokine involved in the inflammation associated with psoriasis, psoriatic arthritis, and some other inflammatory conditions. Taltz was previously authorized for use in patients with moderate to severe plaque psoriasis. Psoriatic arthritis is an immune-mediated inflammatory type of arthritis often present in patients with psoriasis; symptoms of psoriatic arthritis also include joint damage and pain.
The submission provided data from 2 pivotal trials that included patients who had previously tried other biologic DMARDs and those who had not previously tried such drugs. During the trials, patients received Taltz or placebo alone or in combination with a conventional DMARD like methotrexate. Both trials had a primary endpoint of percentage of patients with a 20% reduction in American College of Rheumatology score (ACR20) at Week 24 of treatment. Both trials showed that patients treated with Taltz were significantly more likely to achieve ACR20 than patients treated with placebo. In the trial that included longer term treatment, most patients treated with Taltz maintained the ACR20 improvement from their baseline score after 52 weeks of treatment. In patients with psoriatic arthritis and coexistent moderate to severe plaque psoriasis, more frequent dosing (every 2 weeks instead of every 4 weeks) improved psoriasis symptoms; these patients are therefore recommended to use the already approved plaque psoriasis dosing regimen. The dosing regimen for psoriatic arthritis is 160 mg at Week 0 followed by 80 mg every 4 weeks.
Overall, the safety profile in patients with psoriatic arthritis was similar to the known safety profile in patients with plaque psoriasis. Taltz-treated psoriatic arthritis patients were more likely than placebo-treated patients to have infections (including serious infections), injection site reactions, and hypersensitivity or allergic reactions. There is limited safety data for long-term use of Taltz in psoriatic arthritis patients.
Overall, the benefits of Taltz in patients with psoriatic arthritis outweigh the risks.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.