Sanofi and Regeneron’s Dupixent Wins Expanded Indication in Europe

The European Commission has approved Sanofi’s and Regeneron’s monoclonal antibody Dupixent (dupilumab) for treating severe atopic dermatitis in children who are candidates for systemic therapy.

The biologic is now the only systemic medicine approved in Europe for children six to 11 years old that have severe atopic dermatitis and are eligible for systemic therapy. According to results from the monoclonal antibody’s pivotal trial, nearly three out of four children given the drug showed a 75 percent improvement in extent and severity of disease, with participants seeing an 80 percent improvement on average.

The biologic previously received European approval in August 2019 for treating adolescents 12 to 17 years old with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.