FDA Accepts Arcutis sNDA for Infant Dermatitis, 58% EASI-75 in Phase 2
ARQT•FDA accepted Arcutis’s supplemental NDA for ZORYVE cream 0.05% to treat mild to moderate atopic dermatitis in infants aged 3–24 months, setting a PDUFA action date of February 23, 2027. Phase 2 data in 101 infants showed 58.3% achieved EASI-75 by week 4 and 34.4% achieved vIGA-AD success.
1. sNDA Acceptance and PDUFA Date
FDA accepted the supplemental New Drug Application for ZORYVE cream 0.05% to expand its indication to infants aged 3 to 24 months with mild to moderate atopic dermatitis. The FDA has set a Prescription Drug User Fee Act target action date of February 23, 2027 for the application.
2. Key Clinical Trial Results
The submission is supported by a Phase 2 open-label INTEGUMENT-INFANT study (101 infants) and a Phase 1 pharmacokinetic study (19 infants). In the Phase 2 trial, 58.3% of infants achieved at least a 75% reduction in Eczema Area and Severity Index by week 4 and 34.4% reached vIGA-AD success, with rapid itch relief noted in 46.6% within 10 minutes of application.
3. Market Opportunity and Treatment Profile
Approximately 1 million US children under two receive topical therapy for atopic dermatitis, representing 10% of all topical treatments. If approved, once-daily, steroid-free ZORYVE cream could offer caregivers a non-greasy, non-sensitizing option for sensitive infant skin, addressing a significant unmet need in pediatric eczema care.
