Sanofi (SNYNF,SNY) and Regeneron Pharmaceuticals Inc. (REGN) said that the U.S. Food and Drug Administration has approved Dupixent or dupilumab for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The companies noted that regulatory filings for the age group are underway by the European Medicines Agency and regulatory authorities in additional countries.
According to the company, Children treated with Dupixent and topical corticosteroids achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced itch compared to topical corticosteroids alone at week 16 in a Phase 3 trial.
Long-term safety data from a 52-week open-label extension trial in the age group reinforce the well-established safety profile of Dupixent observed across all other approved age groups.
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood, the companies said in a statement.
Atopic dermatitis is a chronic type 2 inflammatory skin disease. Eighty-five to ninety percent of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, and crusting and oozing.
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