FDA Approves Dupixent for Pediatric Patients Aged Six Months to Five Years With Atopic Dermatitis

The FDA has approved Sanofi and Regeneron’s blockbuster drug Dupixent (dupilumab) for pediatric patients with moderate-to-severe atopic dermatitis who are aged between six months old and five years old and for whom topical prescription therapies aren’t effective.

The injectable drug is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood.

The agency approval was supported by results from a phase 3 study that showed 28 percent of participants achieving clear or almost-clear skin with Dupixent plus low-potency topical corticosteroids (TCS) compared with 4 percent of participants treated with TCS alone.

Dupixent, which first gained FDA approval in 2017 for treatment of adults, made over $6 billion in sales in 2021.