FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

Core Insights - The FDA has approved Arcutis Biotherapeutics' ZORYVE (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years, providing a steroid-free alternative for long-term use [1][6][23] - Approximately 1.8 million children in the U.S. aged 2 to 5 are treated for atopic dermatitis, highlighting a significant market need for effective treatments [2][6] - ZORYVE cream demonstrated rapid and significant improvements in clinical trials, with 40% of children achieving a 75% improvement in eczema symptoms within four weeks [2][12] Company Overview - Arcutis Biotherapeutics is focused on developing innovative treatments for immune-mediated dermatological diseases, with a growing portfolio of advanced topical therapies [30] - The approval of ZORYVE cream 0.05% marks the sixth FDA approval for the ZORYVE product line in just over three years, indicating strong regulatory momentum [1][6] - The company aims to ensure predictable access to ZORYVE through patient support programs, including the ZORYVE Direct Program and Arcutis Cares™ for financially eligible patients [4][30] Clinical Data - The FDA approval was based on results from the INTEGUMENT-PED Phase 3 trial, which involved 652 children and demonstrated rapid disease clearance and safety [10][11] - In the INTEGUMENT-PED trial, 25.4% of children treated with ZORYVE achieved a 'Clear' or 'Almost Clear' status by Week 4, compared to 10.7% in the vehicle group [12] - The long-term extension study (INTEGUMENT-OLE) showed that 71.9% of participants maintained a 75% improvement in eczema severity after 56 weeks of treatment [16] Market Context - Atopic dermatitis affects approximately 9.6 million children in the U.S., with a significant impact on family life due to sleep disruption and emotional distress [19][20] - ZORYVE is positioned as a leading topical therapy for atopic dermatitis, with recognition from industry awards, including Allure's "2025 Best of Beauty Breakthrough Award" [22][21] - The product's formulation targets underlying inflammation without compromising the skin barrier, making it particularly suitable for young children [3][21]