Regulatory Decision Summary for Humira
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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of the submission is to extend the indication of HUMIRA for Polyarticular Juvenile Idiopathic Arthritis (JIA) to pediatric patients aged 2 to < 4 years.
Why was the decision issued?
The efficacy and safety were evaluated in an open-label clinical trial conducted in children with polyarticular JIA, aged 2 to < years. The results obtained from this trial showed that the efficacy and the safety profiles of HUMIRA for the treatment of children with polyarticular JIA aged to 2 to < 4 years are similar to those previously established in children aged 4 to 17 years. No overall differences were observed in the efficacy and safety between the two age groups.
No other changes in the conditions of use of HUMIRA were made.
In order to ensure that this benefit continues to outweigh any risk after authorization of HUMIRA for the above-mentioned age group (2 to < 4 years), Health Canada has required several post-approval activities to be carried out as well as a Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.