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.
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What was the purpose of this submission?
The purpose of this submission is to seek market authorization to remove the upper age limit of 17 years of age for Polyarticular Juvenile Idiopathic Arthritis (JIA).
Why was the decision issued?
The efficacy and safety were evaluated by comparing two patient cohorts of a pivotal study: the patients who were under 18 years of age at the end of the study and the patients who reached 18 years of age during the clinical study. An analysis of the efficacy by aligning the patients with the turning point when they reached 18 years of age was also performed, the responses were then compared before and after the turning point.
With acknowledgement of the inherent limitations of a long-term extension study and post-hoc analysis, the totality of evidence indicates that based on the responses as defined by the American College of Rheumatology pediatric 30 (PedACR 30), there is no apparent difference in efficacy after pediatric patients reached 18 years of age. No major differences in safety profiles were observed between the two cohorts.
Therefore, the benefit-risk ratio of Humira in the treatment of polyarticular JIA patients who reached adulthood remains favorable.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.