The U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Across all approved indications globally, more than 150,000 patients have been treated with Dupixent. Currently, in Europe Dupixent is used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry). Dupixent is also used to treat severe asthma in patients aged 12 years or over whose asthma is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma. A Paediatric Investigation Plan was presented and evaluated by European Medicines Agency to study the medicine in children from 2 years to 18 years old affected by atopic dermatitis, as part of a paediatric investigation plan*. The plan includes the development of a specific pharmaceutical form to be used in children*, solution for injection. It also includes a proposal to show efficacy and safety of the medicine in clinical studies. The future indication proposed for children is: treatment of moderate to severe atopic dermatitis (e.g., IGA ≥3) in paediatric patients from 6 months to less than 18 years of age, who are not adequately controlled with, or who are intolerant to topical medications. The agreed completion of all the studies and trials included in the Paediatric Investigation Plan is July 2022.
