Core Viewpoint - Arcutis Biotherapeutics has initiated a Phase 2 open-label study for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis, marking a significant step in addressing unmet needs in pediatric dermatology [1][2][3] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent needs in dermatological diseases [15] Study Details - The INTEGUMENT-INFANT study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate atopic dermatitis, evaluating the safety and tolerability of roflumilast cream applied once daily over four weeks [3][9] - This study builds on previous successful results from the ARQ-151-105 (MUSE) study, which also evaluated roflumilast cream in infants [3] Atopic Dermatitis (AD) Insights - Atopic dermatitis is a chronic condition affecting approximately 9.6 million children in the United States, with up to 60% of cases developing symptoms within the first year of life [5][9] - The condition significantly impacts families by disrupting sleep and increasing the risk of skin infections, highlighting the need for effective treatments [2] ZORYVE Product Information - ZORYVE is the first and only branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, representing a next-generation topical PDE4 inhibitor [6][7] - ZORYVE cream 0.15% is currently under FDA review for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, with a target action date of October 13, 2025 [8]

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].