Research & Development
Sanofi granted EU approval of Dupixent for young children with severe atopic dermatitis
21 March 2023 -

French healthcare company Sanofi S.A. (Euronext Paris: SAN) (Nasdaq: SNY) announced on Tuesday that the European Commission has approved Dupixent (dupilumab) in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years who are candidates for systemic therapy.

Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the United States.

Atopic dermatitis is a chronic type 2 inflammatory skin disease with a majority of patients first developing symptoms before 5 years of age. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids, which can be associated with safety risks and may impair growth when used over a long period.

The Commission's approval was based on data from a Phase 3 trial which showed that Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo.

Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.