Sanofi : EU Approves Dupixent To Treat Severe Atopic Dermatitis In Children

(RTTNews) - The European Commission approved Dupixent or dupilumab to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy, Sanofi - Aventis Groupe said in a statement on Tuesday.

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood.

The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks plus low-potency topical corticosteroids or TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population.

The company stated that Dupixent also improved sleep quality, skin pain and health-related quality of life compared to placebo in both the overall and severe populations. Long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks.

Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites.

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan.

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

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