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This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.
The European Commission (EC) has approved Dupixent (dupilumab) in the European Union to treat severe atopic dermatitis in children six months of age to five years of age who are candidates for systemic therapy. This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.
Dupixent is a subcutaneous injection at different injection sites and is intended for use under the guidance of a healthcare professional. It can be given in a clinic or at home by self-administration after training by a healthcare professional.
The approval is based on data from a Phase III trial that evaluates Dupixent every four weeks plus low-potency primarily topical corticosteroids (TCS) or TCS alone in 162 children between six months of age to five years of age with moderate-to-severe atopic dermatitis. The medicine improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to placebo in the overall enrolled population.
In addition, Dupixent improved sleep quality, skin pain, and health-related quality of life compared to placebo in both the overall and severe populations, and the long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks, according to the Sanofi.
Common side effects across all indications include injection site reactions, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia.