Regulatory Decision Summary for Dupixent
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 expand the indication for Dupixent to include add-on maintenance treatment in patients aged 6-11 years with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid-dependent asthma. The currently authorized indication for severe asthma is limited to patients aged 12 years and older. The addition of a new 100 mg/0.67 mL pre-filled single-use syringe (PFS) was also proposed.
After evaluation of the submitted data package, Health Canada authorized the proposed indication, as well as the 100/0.67 mL PFS.
Why was the decision issued?
- Asthma is an inflammatory disorder of the airways; severe asthma refers to a subset of asthmatic patients who have poorly controlled asthma despite following best treatment practices. These patients are at a greater risk of death, severe exacerbations, co-morbidities, poor quality of life, and a greater reliance on medications associated with side effects, compared to patients with milder forms of the disease. For children with severe disease, based on a phenotypic assessment, targeted biologics may be recommended in addition to the use of inhaled corticosteroids and/or additional controller medications.
- Authorization was based on a Phase 3, 52-week, randomized, double-blind, placebo-controlled study (VOYAGE). Patients (n = 408) aged 6 to 11 years of age with moderate-to-severe asthma on a medium- or high-dose inhaled corticosteroid (ICS) and a second controller medication or high-dose ICS alone received either Dupixent (n = 273) or placebo (n = 135) in addition to their standard of care. The dose administered was weight-based (≥15 kg to <30 kg: 100 mg every other week (Q2W); ≥30 kg: 200 mg Q2W). This is the authorized dosing regimen. In addition, a 300 mg every four weeks (Q4W) dosing regimen for patients weighting ≥15 kg to <60 kg has also been authorized based on pharmacokinetic modeling.
- The primary endpoint was the annualized rate of severe exacerbation events during the 52-week treatment period. The key secondary endpoint was the change from baseline in percent predicted pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) at Week 12 to assess improvement in lung function. There was a statistically significant benefit for dupilumab compared to placebo for these endpoints, as well as other clinically meaningful secondary endpoints.
- Commonly reported adverse events (≥5%) that occurred more frequently in patients receiving dupilumab included: viral upper respiratory tract infection, eosinophilia, injection site erythema, injection site oedema, and injection site nodule. The safety profile was consistent with the established profile in adults and adolescents with the same disease, with the exception of the additional adverse drug reaction of helminth infections. The risks are labeled in the product monograph.
- Overall, the anticipated benefits of Dupixent are expected to outweigh its risk when used under the conditions of use recommended in the Dupixent (dupilumab) product monograph, at this time.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations