Regulatory Decision Summary for Ilaris
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?
Ilaris (canakinumab) is authorized for Systemic Juvenile Idiopathic Arthritis (SJIA), also known as Stills disease, in patients aged 2 years and older. This submission was to expand the authorization to include Adult-onset Stills Disease (AOSD).
Why was the decision issued?
Adult-onset Stills Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) are rare diseases with similar clinical presentations which include fever, arthritis, rash and elevated inflammatory markers. The current understanding of the diseases support that they are part of the same disease continuum rather than two separate diseases.
The efficacy of Ilaris (canakinumab) in adults with AOSD was based on the pharmacokinetic exposure and extrapolation of the established efficacy of Ilaris in SJIA patients. Efficacy of Ilaris was also assessed in Study GDE01T, a randomized, double-blind, placebo-controlled study that enrolled 36 patients (22 to 70 years old) diagnosed with AOSD. The results were generally consistent with the results of a pooled efficacy analysis of SJIA patients based on a Bayesian analysis.
In study GDE01T, a higher proportion of Ilaris-treated patients compared to placebo-treated patients reported Stills disease flare, drug induced liver injury, hepatotoxicity, angioedema and infections (including opportunistic infections). These adverse events were similar to what was observed in SJIA patients.
In Canada, there are no approved treatment for AOSD. In the context of the unmet medical need for treatment, the data evaluated in this submission are considererd sufficient to establish a favorable benefit/risk profile of Ilaris in providing a treatment option for AOSD patients.
Finally, as part of post-market surveillance commitments, the sponsor will submit Periodic Safety Update Reports (PSURs) with overall safety and updated benefit evaluation in all authorized indications, including AOSD.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.