U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis

Core Viewpoint - Arcutis Biotherapeutics has announced the FDA's acceptance of a supplemental New Drug Application for ZORYVE (roflumilast) cream 0.05%, aimed at treating mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years, with a target action date set for October 13, 2025 [1][5]. Group 1: Product Efficacy and Safety - Clinical trials have demonstrated significant positive results for ZORYVE cream 0.05% in treating AD in young children, highlighting its efficacy and favorable safety profile, which is crucial for long-term treatment in this demographic [2][3]. - The pivotal INTEGUMENT-PED Phase 3 trial involved 652 children aged 2 to 5 years, showing that ZORYVE cream 0.05% was well-tolerated, with a low incidence of adverse events [4][5]. - At Week 4, 25.4% of children treated with ZORYVE cream achieved vIGA-AD Success, compared to 10.7% for the vehicle group, indicating a statistically significant improvement (P<0.0001) [6]. Group 2: Market Potential - If approved, ZORYVE cream 0.05% will provide a new treatment option for approximately 1.8 million children aged 2 to 5 with AD in the United States, addressing a significant unmet need in pediatric dermatology [3][5]. - The company aims to offer an alternative to steroids with this new targeted topical therapy, potentially advancing the standard of care for young children suffering from AD [3][5]. Group 3: Company Background - Arcutis Biotherapeutics is a commercial-stage medical dermatology company focused on innovations for immune-mediated dermatological diseases, with a growing portfolio that includes three FDA-approved products [11].