Regulatory Decision Summary for Dupixent

The purpose of this Supplement to a New Drug Submission (SNDS) was to seek market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations for Dupixent (dupilumab injection) to expand the atopic dermatitis indication to include patients 6 months to 5 years of age.

The proposed indication was supported by clinical data from one pivotal and two supportive clinical studies. One pivotal, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent added to standard-of-care low-potency topical corticosteroids (TCS) compared to placebo added to low-potency TCS in 162 children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. Patients treated with Dupixent received either 200 mg or 300 mg (based on weight) every four weeks.

The primary endpoint assessed the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0 or 1; the key secondary endpoint was Eczema Area and Severity Index-75 (EASI-75) response at Week 16. Patients who completed the trial were eligible to enroll in an open-label extension to assess the safety and efficacy of long-term treatment with Dupixent in this age group.

Results showed that adding Dupixent to TCS improved skin clearance and reduced overall disease severity and itch compared to placebo added to TCS at 16 weeks in a clinically meaningful and statistically significant manner. A lower proportion of Dupixent patients needed rescue medications, compared to those on placebo.

The safety of Dupixent + TCS was assessed in the pivotal study and in a supportive study. Adverse events (AEs) that were more commonly observed with Dupixent included conjunctivitis, herpes viral infections, molluscum contagiosum, rhinorrhea, and dental caries. There were no deaths and no serious AEs related to Dupixent treatment. There were no reports of anaphylactic reaction related to Dupixent treatment, and no evidence of increased risk of serious infections. The safety profile of Dupixent + TCS in these patients through Week 16 was consistent with the safety profile from studies in adults and pediatric patients 6 to 17 years of age with Atopic dermatitis (AD).

The long-term safety of Dupixent + TCS was also assessed in an open-label extension study of 180 patients 6 months to 5 years of age with AD. Most subjects were treated with Dupixent 300 mg every 4 weeks. The safety profile of Dupixent + TCS in subjects followed through Week 52 was similar to the safety profile observed through Week 16 in the pivotal study. The long-term safety profile of Dupixent + TCS observed in pediatric subjects 6 months to 5 years of age was consistent with that seen in adults and pediatric patients 6 to 17 years old with AD. The number of pediatric patients in the 6 months to 2 years age group was however relatively low which limits the analysis of the long-term safety profile for this subgroup.

Overall, the benefits of Dupixent outweigh its risks in pediatric patients aged 6 months to 5 years with atopic dermatitis. The benefit/risk profile of the drug is considered favourable in the target patient population.

An updated Risk Management Plan (RMP) for Dupixent was reviewed by Health Canada and considered acceptable.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

A Notice of Compliance was recommended.

For further details about Dupixent, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.