European Commission approves Dupixent to treat adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis

The European Commission (EC) extended the marketing authorization for Dupixent (dupilumab) from Sanofi + Regeneron in the European Union (EU) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent is now the first biologic medicine approved in the EU to treat these patients.

Efficacy and Safety from Clinical Trials-The EC approval is based on clinical data from the LIBERTY AD program, including a pivotal Phase III trial and an open-label extension trial evaluating the efficacy and safety of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis. Key data points from the pivotal trials at 16 weeks include: More than five times as many Dupixent patients experienced at least 75% improvement in disease extent and severity compared to placebo: 42% of patients who received Dupixent achieved 75% or greater skin improvement compared to 8% with placebo, as measured by the Eczema Area and Severity Index (EASI-75), the co-primary endpoint of the trial. More than 10 times as many Dupixent patients had clear or almost clear skin compared to placebo: 24% of patients who received Dupixent achieved clear or almost clear skin compared to 2% with placebo, as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, the co-primary endpoint of the trial. Dupixent patients experienced a 66% average improvement in the EASI score of skin inflammation from baseline compared to 24% for placebo. More than seven times as many Dupixent patients experienced significantly less itch compared to placebo: 37% of patients who received Dupixent achieved a clinically meaningful improvement in itch of at least four points on the Peak Pruritus Numerical Rating Scale (NRS) compared to 5% with placebo.

More than three times as many Dupixent patients experienced significant improvements in health-related quality of life compared to placebo: 61% of patients who received Dupixent achieved a clinically meaningful improvement in quality of life of at least six points on the Children’s Dermatology Life Quality Index (CDLQI) compared to 20% with placebo. More than six times as many Dupixent patients reported significant improvements in disease severity compared to placebo: 63% of patients who received Dupixent reported a clinically meaningful improvement in disease severity of at least six points on the Patient Oriented Eczema Measure (POEM), which is a composite measure that includes sleep, compared to 10% with placebo.