FDA accepts sBLA for Dupixent in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis. - Sanofi + Regeneron

The FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) from Sanofi + Regeneron, in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate-to-severe atopic dermatitis. The target action date for the FDA decision is March 11, 2019.

The sBLA is supported by data from a pivotal Phase III trial evaluating the efficacy and safety of Dupixent monotherapy in adolescent patients with moderate-to-severe atopic dermatitis, which were presented at the European Academy of Dermatology and Venereology in September 2018.