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 purpose of this New Drug Submission (NDS) is to pursue authorization for the indication for Taltz (ixekizumab) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Why was the decision issued?
The benefit/risk ratio of Taltz for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy is considered acceptable for the following reasons:
Benefit
During the induction phase (12 weeks), efficacy of the treatment with the recommended ixekizumab dosing regimen was demonstrated by achieving co-primary endpoints of PASI 75 and sPGA of 0 or 1, as well as the secondary endpoint of PASI 90 in each of the pivotal trials (UNCOVER -1, UNCOVER -2 and UNCOVER -3).
Based on the results of the study UNCOVER -1 the benefits were maintained up to 60 weeks.
Risk
The reported safety profile of ixekizumab is in line with that of other biological products authorized for treatment of psoriasis.
In order to ensure that the benefit continues to outweigh any risks after authorization, Health Canada has required several post-approval activities to be carried out.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TALTZ | 02455110 | ELI LILLY CANADA INC | IXEKIZUMAB 80 MG / ML |
| TALTZ | 02455102 | ELI LILLY CANADA INC | IXEKIZUMAB 80 MG / ML |