Regulatory Decision Summary for Dupixent

The benefits of Dupixent as an add-on maintenance treatment in patients aged > 6 and < 12 years with moderate to severe atopic dermatitis was primarily demonstrated in a phase 3 double-blind, placebo-controlled trial (AD-1652), supported by a phase 2b pharmacokinetic open-label study (AD-1412), and a phase 3 open-label extension trial (AD-1434).

In the pivotal trial, AD-1652, Dupixent resulted in a favourable reduction in Investigator Global Assessment (IGA) score and Eczema Assessment Severity Index (EASI) score from baseline to Week 16. A numerically greater proportion of subjects receiving Dupixent had an IGA score of 0 or 1 at week 16. Similarly, a numerically greater proportion of subjects receiving Dupixent had a reduction of at least 75% of their EASI score from baseline. Additional measures of disease extent, severity and impact on disease burden and quality reflected a favourable response to treatment. Results of the open-label extension trial at week 52 were consistent with the results seen at week 16.

In AD-1652, the incidence of adverse events (AEs) was generally consistent when comparing Dupixent to placebo. There were few serious AEs, AEs of special interest, and discontinuations due to AEs reported in the pivotal clinical trial. Treatment-emergent AEs were generally of mild-to-moderate intensity. The most frequently reported treatment-emergent AEs were injection site reaction and conjunctivitis. The safety of Dupixent in children with moderate to severe atopic dermatitis is considered consistent with the established risk profile for Dupixent.

Overall, the benefit-risk profile for Dupixent (dupilumab injection) is considered to be positive, which supports an extension to the indication as an add-on maintenance treatment in patients aged > 6 to < 12 with moderate to severe atopic dermatitis.