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 submission was to seek approval for the use of STELARA (ustekinumab) for the treatment of moderately to severally active Crohns disease (CD) in patients who failed prior therapies and a new dosage form with 130 mg ustekinumab in 26 mL (5 mg/mL for intravenous injection.
STELARA is a fully human immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb) that binds with high affinity to human IL-12 and IL-23. This selective immunomodulator was initially authorized by Health Canada for the treatment of psoriasis and Psoriatic Arthritis (PsA).
STELARA is indicated for the treatment of adult patients with moderately to severely active Crohns disease, who have had an inadequate response with, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids.
Why was the decision issued?
The benefit of STELARA in patients with moderately to severely active Crohns disease was demonstrated by efficacy data from three phase 3 placebo controlled clinical trials. A significantly higher proportion of patients treated with STELARA achieved clinical response at Week 6 and remission at Week 44 as compared to placebo. In addition, a higher proportion of patients who received STELARA were corticosteroid-free and in clinical remission at Week 44, compared to placebo.
The overall safety profile of STELARA was similar to that observed in the psoriasis and psoriatic arthritis clinical studies. Serious adverse events will be followed by pharmacovigilance. Post-market safety will be managed with labeling, the on-going open-label, long-term Study IM-UNITI and the Risk Management Plan (RMP) to further evaluate risks associated with the use of ustekinumab.
In patients who have had an inadequate response with, loss of response to, or were intolerant to prior therapies, STELARA provides alternative treatment options. The benefit is considered to outweigh the risk.
This submission supports STELARA for the treatment of adult moderate to severe Crohns Disease and is considered to be compliant with section C.08.002 of the Food and Drug Regulations.
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 |
|---|---|---|---|
| STELARA I.V. | 02459671 | JANSSEN INC | USTEKINUMAB 5 MG / ML |