FDA Approves Dupixent for Young Children with Atopic Dermatitis

Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.

The FDA has approved Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. It is approved for young children whose disease is not adequately controlled with topical prescription therapies.

“Moderate-to-severe atopic dermatitis in babies and young children is more than just a rash – the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed,” Julie Block, president and chief executive officer at National Eczema Association, said in a press release. “Caregivers do their best to manage skincare routines multiple times a day, but for many, topical treatments are not enough.”

The approval is based on data from a phase 3 trial evaluating Dupixent every four weeks plus topical corticosteroids or topical corticosteroids alone. The trial met the primary and all secondary endpoints. At 16 weeks, 28% of patients who received Dupixent with topical corticosteroids achieved clear or almost-clear skin compared with 4% with placebo, the primary endpoint. Additionally, 48% achieved clinically meaningful reduction in itch compared with 9% with placebo.

The safety profile of Dupixent was similar to the safety profile in patients 6 years and older with atopic dermatitis. Hand-foot-and-mouth disease and skin papilloma were, respectively, reported in 5% and 2% of Dupixent patients, and none of these cases led to treatment discontinuation.

Dupixent is a human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is being developed jointly by Sanofi and Regeneron.

Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis in different age populations. Its most recent approval in May 2022 was to treat patients with eosinophilic esophagitis, an inflammatory condition that causes the esophagus to narrow and makes it difficult to eat.

Related: FDA Approves Dupixent for Eosinophilic Esophagitis

Additionally, a supplemental application for Dupixent is being by U.S. regulators to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is Sept. 30, 2022.

Related: FDA Accepts Dupixent Application for Treating Skin Lesions