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.
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What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission (SNDS) was to obtain market authorisation in Canada for Ilaris (canakinumab; an interleukin-1 beta inhibitor) for the treatment of three periodic fever syndromes in adult and paediatric patients, including Tumour Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF). In FMF, Ilaris can be given as monotherapy or in combination with colchicine.
Health Canada authorised the recommended starting dose of 150 mg in patients with body weight >40 kg, and 2 mg/kg in patients with body weight ≤40 kg, administered every four weeks as a single dose via subcutaneous injection. If a satisfactory clinical response has not been achieved 7 days after the first dose, a second dose of Ilaris at 150 mg or 2 mg/kg can be administered.
Why was the decision issued?
The efficacy and safety of Ilaris for the treatment of TRAPS, HIDS/MKD and FMF was demonstrated in a single, pivotal, controlled study. The primary objective of the pivotal trial was achieved in all 3 periodic fever syndromes (crFMF, HIDS/MKD, TRAPS) disease cohorts. ILARIS was superior to placebo for all 3 cohorts in the proportion of patients who resolved their index disease flare at Day 15 and had no new flare during the remainder of the 16 week treatment period. Limited long-term efficacy data is available after Week 16.
Overall, the safety profile of ILARIS for the proposed new indications in the target patient population was acceptable and consistent with that previously known for this biologic therapy and was captured in the Product Monograph.
The Risk Management Plan (RMP) for Ilaris was reviewed by Health Canada. The sponsor accepted, as a post-marketing commitment, to revise the RMP with the pharmacovigilance plan for monitoring and characterisation of potential safety concerns raised by Health Canada.
The demonstrated benefits of ILARIS outweigh its risks for the three periodic fever syndrome indications, as specified in the Product Monograph.
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 |
|---|---|---|---|
| ILARIS | 02460351 | NOVARTIS PHARMACEUTICALS CANADA INC | CANAKINUMAB 150 MG / ML |