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 was to seek authorization for the use of Humira in the treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Why was the decision issued?
Pediatric non-infectious chronic anterior uveitis is a rare disease with a high risk of permanent blindness. The standard of care for these patients generally includes topical or systemic corticosteroids as well as immunomodulatory agents such as mycophenolate and methotrexate. The authorization of Humira for this indication adds an additional option for patients.
Authorization was based on the totality of evidence gathered from an investigator initiated study (the SYCAMORE trial) and pharmacokinetic modeling, as well as the well-established history of safety and efficacy in many autoimmune conditions treated with Humira. These studies demonstrated that the use of the proposed dose of Humira led to delay in treatment failure and achieved plasma levels of drug similar to that observed in adult uveitis trials. Additionally, no new safety signals were observed in the evidence provided. The most common adverse events observed in the SYCAMORE trial were infections and infestations, respiratory, thoracic and mediastinal disorders, injection site reactions, gastrointestinal disorders, nervous system disorders as well as musculoskeletal and connective tissue disorders. These are known adverse events associated with the use of Humira for other authorized pediatric indications.
The overall risk-benefit profile of Humira is considered favorable for use in pediatric non-infectious chronic anterior uveitis. Potential risks associated with the use of Humira are considered to be adequately mitigated by product labelling and routine pharmacovigilance activities.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.