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.


Product type:

Drug

Medicinal ingredient(s):

Ixekizumab

Therapeutic area:

Immunosuppressants

Type of submission:

Supplement to a New Drug Submission (SNDS)

Control number:

238580
What was the purpose of this submission?

 

The purpose of this submission was to extend the authorised indication for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy to pediatric patients aged 6 to 17 years. After evaluation of the of the submitted data package, Health Canada authorized Taltz for the following indication: "Taltz (ixekizumab) is indicated for the treatment of pediatric patients from 6 to less than 18 years of age with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy."

 

Why was the decision issued?

 

The authorization of this new indication was based on one international, multi-centre, randomized, double-blind, placebo-controlled trial, I1F-MC-RCHD (IXORA-Peds). Patients (n = 171) with moderate-to-severe plaque psoriasis were randomized 2:1 to receive either (Taltz) (n = 115) based on their body weight at baseline (subcutaneous doses of 40, 80, or 160 mg at week 0 and then 20, 40, 80 mg dose, respectively, every 4 weeks thereafter; or a matched placebo (n = 56).

In IXORA-Peds, the co-primary efficacy endpoints were the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) 75 response at 12 weeks and the proportion of patients achieving a static Physicians Global Assessment (sPGA) response of "0" (clear) or "1" (minimal) at 12 weeks. After 12 weeks, Taltz-treated patients demonstrated a clinically superior response compared to placebo patients on these measures. The Taltz-treated patients responses to key secondary endpoints (PASI 90 response, PASI 100 response, and sPGA "0" (clear) response, all at week 12) were also clinically superior to those of placebo patients, supporting the primary efficacy results. The efficacy responses of Taltz-treated patients were compared to those previously demonstrated for Taltz in the adult moderate-to-severe plaque psoriasis population and were found to be consistent.

The safety profile of Taltz in pediatric patients is generally consistent with that previously established for adults with the exception of increased rate of reports of inflammatory bowel disease, specifically Crohns disease, in pediatric patients. These reports have been adequately communicated in the recommended product monograph and inflammatory bowel disease will continue to be monitored as an important identified risk post-market, as set out in the Taltz Risk Management Plan.

The benefit/risk profile of Taltz in the target pediatric population (moderate-to-severe plaque psoriasis in patients 6 to less than 18 years of age) is favourable.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.