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The FDA has accepted a supplemental New Drug Application (NDA) for roflumilast 0.05% cream for treating mild-to-moderate atopic dermatitis (AD) in children aged 3-24 months, according to a press release from the manufacturer Arcutis Biotherapeutics.
Roflumilast 0.05% (Zoryve), a topical phosphodiesterase-4 inhibitor, is currently approved for treating mild-to-moderate AD in children aged 2 years or older; it was approved for treating AD in children aged 2-5 years in 2025. A 0.15% cream formulation is approved for treating AD in adults and children aged 6 years or older.
The supplemental NDA is supported by data from phase 1 and phase 2 open-label studies of children aged 3 months to younger than 24 months with mild-to-moderate AD. Data from the phase 2 study were presented at the American Academy of Dermatology (AAD) 2026 Annual Meeting.
The study enrolled 101 children aged 3 months up to 2 years with mild-to-moderate AD; 96 completed 4 weeks of treatment. Of these, 34.4% achieved a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline on the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Of the 40 participants with baseline scalp involvement, approximately 67.5% achieved a vIGA-scalp score of 0 or 1 at week 4.
More than half ( 58%) of the infants achieved a 75% improvement in the Eczema Area and Severity Index at week 4. In addition, nearly half (46.6%) of the participants experienced relief from itching, defined as at least a 25% improvement from baseline according to the Dynamic Pruritus Scale within 10 minutes of applying the cream, according to caregiver reports.
Safety data were similar to those seen in previous studies involving older patients. No serious adverse events were reported in the INTEGUMENT-INFANT study. The most common adverse events, reported in 3% or more of the study participants, included diarrhea, vomiting, upper respiratory tract infection, and nasopharyngitis.
The Prescription Drug User Fee Act target action date for the approval decision is February 23, 2027. The 0.15% cream formulation of roflumilast was recently approved for treating psoriasis in children down to age 2.
