Regulatory Decision Summary for Dupixent

Authorization was based on a pivotal, phase 3 study in adolescent patients with moderate-to-severe atopic dermatitis, an open label extension study, as well as supportive phase 1 and phase 2 studies. The randomized, double blind, and placebo controlled phase 3 study evaluated a weight-based dosing regimen as well as safety, efficacy, and immunogenicity.

The co-primary endpoints were the proportion of patients with IGA 0 or 1 (clear or completely clear) and the proportion of patients with EASI-75 (75% improvement from baseline) at week 16. The results demonstrated statistically significant and clinically meaningful differences compared to placebo favouring active treatment. The IGA 0 or 1 response rate was 24.4%, 17.9% and 2.4% in the Q2W, Q4W and placebo groups, respectively; the EASI-75 response rates were 41.5%, 38.1% and 8.2% in the Q2W, Q4W and placebo groups, respectively. Weight-based dosing (200 or 300 mg) in the Q2W group provided more consistent drug exposure than 300 mg fixed dosing Q4W and was in line with dosing authorized in adult populations. These findings were consistent in the key secondary endpoints and, taken together, support the efficacy of Dupixent for adolescent AD.

Despite the smaller sample size (N=251) compared to the adult studies, the safety profile for adolescents was similar to adult AD patients treated with Dupixent. No new adverse reactions or new safety signals were observed in the study compared to the adult AD program.

Dupixent is considered to have a favorable Benefit/Risk profile for the treatment of patients aged 12 and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.