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# Dupixent Approved for Pediatric Atopic Dermatitis
- URL: https://www.fdaweb.com/dupixent-approved-for-pediatric-atopic-dermatitis/
- Published: 2022-06-08T12:00:00.000Z
- Updated: 2026-09-14T17:47:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152009

FDA has approved Sanofi’s Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not recommended. 

Approval is based on data that include a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids (TCS) or TCS alone (placebo), according to the company. The trial met the primary and all secondary endpoints. The data showed that 28% of patients on Dupixent with TCS achieved clear or almost-clear skin compared to 4% with placebo, the primary endpoint. Additionally, 53% of Dupixent patients achieved 75% or greater improvement in overall disease severity from baseline compared to 11% with placebo, Sanofi says. 

Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis or eosinophilic esophagitis in different age populations.