EU regulator approves Sanofi, Regeneron's Dupixent for adolescents with moderate-to-severe atopic dermatitis

Sanofi and Regeneron Pharmaceuticals announced Tuesday that the European Commission expanded approval of Dupixent (dupilumab) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. The companies noted that the drug is "the first biologic medicine approved in the EU to treat these patients."

Commenting on the approval, Regeneron's chief scientific officer George Yancopoulos said it "provides these young patients with a treatment option that addresses the type 2 inflammation that underlies atopic dermatitis." Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the IL-4 and IL-13 proteins, which are key drivers of type 2 inflammation.

The decision by the European Commission is based on data from the LIBERTY AD programme, including a Phase III trial evaluating the efficacy and safety of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis. Results from the studies showed that at 16 weeks, 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). Meanwhile, 24% of those 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.

Dupixent is currently approved in the EU for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. It is also authorised in Europe for adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide, who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment. EU regulators are currently reviewing the drug for the treatment of chronic rhinosinusitis with nasal polyposis.

Separately on Tuesday, Sanofi and Regeneron reported that a Phase III study of Dupixent to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints. Results showed that adding Dupixent to standard-of-care topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearing, itching and health-related quality of life, compared to TCS alone.

"The results from this trial, the first to assess a biologic medicine in children under 12 with atopic dermatitis, are very important because of the significant unmet needs in this patient population," remarked Yancopoulos. The companies plan to submit data from the study to the FDA in the fourth quarter, with other regulatory bodies to follow, while detailed findings will be presented at a future medical conference.

Last month, Sanofi said that second-quarter sales of Dupixent rose 181.8% to €496 million ($555 million), driven by continued growth in atopic dermatitis. For related analysis, see Physician Views snap poll results - Dupixent satisfaction rates sky high, but demand for oral alternatives is real, and Physician Views snap poll results - More data support threat of JAK inhibitors to Dupixent in atopic dermatitis.

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