Regulatory Decision Summary for Stelara
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 SNDS was to seek marketing authorisation for Stelara (ustekinumab) for the treatment of adult patients with moderate to severe Ulcerative Colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic, or have medical contraindications to such therapies.
Why was the decision issued?
Authorization was based on two randomized, double-blind, placebo-controlled, clinical trials in adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response to or failed to tolerate a biologic (i.e., anti-TNFa agent and/or vedolizumab) or conventional therapy. An 8-week intravenous (IV) induction study (UNIFI-I) was followed by a 44-week subcutaneous (SC) randomized withdrawal maintenance study (UNIFI-M) representing a total 52 weeks of therapy. The UNIFI-I study included 961 patients who received Stelara IV 120 mg (n=320), Stelara IV ~6 mg/kg (n=322) or placebo (n=319). The UNIFI-M study included 523 patients who received Stelara 90 mg SC every 8 weeks (n=176), Stelara 90 mg SC every 12 weeks (n=172) or placebo (n=175).
The primary efficacy objective of the induction study was the achievement of induction of clinical remission. The major secondary objectives were the induction of clinical response and endoscopic healing. The primary efficacy objective of the maintenance study was to evaluate clinical remission in subjects induced into clinical response. The major secondary objectives were the maintenance of clinical response and endoscopic healing in subjects induced into clinical response. Both studies achieved the primary objectives of the treatment effect.
The overall safety profile of Stelara in the UC studies is consistent with the safety profile observed in other patient populations. No new safety signals were detected. Identified safety risks are presented in the Canadian Product Monograph.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.