Core Viewpoint - Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA to expand the indication of ZORYVE (roflumilast) cream 0.3% for treating plaque psoriasis in children as young as 2 years old, potentially making it the first topical PDE4 inhibitor for this age group [1][7]. Group 1: Product Information - ZORYVE cream is a once-daily, steroid-free, non-greasy formulation that avoids sensitizing excipients and irritants, making it suitable for sensitive skin areas [3][7]. - The cream is currently approved for plaque psoriasis in patients aged 6 and older, and the sNDA is supported by data from a 4-week study in children aged 2 to 5 years, demonstrating favorable long-term safety and efficacy [4][8]. Group 2: Market Need - There is a significant unmet need for effective, non-steroidal treatment options for plaque psoriasis in children under 6, particularly for those with sensitive skin [2][5]. - Plaque psoriasis is the most common form of psoriasis in young children, often affecting sensitive areas like the face and intertriginous regions, which complicates long-term management [2][5]. Group 3: Company Commitment - Arcutis aims to establish ZORYVE as a foundational therapy for young children with inflammatory skin diseases, addressing historical gaps in treatment options studied for pediatric patients [4][14]. - The company is dedicated to conducting trials of ZORYVE in pediatric patients across various inflammatory skin diseases to enhance treatment availability [4][14].

Core Insights - Arcutis Biotherapeutics, Inc. is presenting five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, showcasing new data on the long-term safety and efficacy of ZORYVE cream in treating atopic dermatitis (AD) in children aged 2 to 5 [1][2] Group 1: Study Findings - The INTEGUMENT-OLE study demonstrated that ZORYVE cream 0.05% has long-term safety and durable efficacy in children aged 2 to 5 with AD, with a median duration of disease control of 238 days for those switching to a proactive twice-weekly application [2][5] - In the study, 32.7% of participants aged 6 years and older and 28.8% of participants aged 2 to 5 achieved a validated Investigator Global Assessment (vIGA-AD) score of clear or almost clear by Week 4, improving to 55.7% and 63.1% respectively by Week 52 [3][5] - Significant improvements in itch were observed, with 30.9% of participants aged 6 years and older and 41.2% of participants aged 2 to 5 achieving a clinically meaningful reduction in itch at the conclusion of the parent studies, improving to 55.3% and 60.7% respectively after up to 56 weeks of treatment [3][5] Group 2: Clinical Implications - The data highlight the critical need for effective, long-term, steroid-free treatment options for young children with AD, as chronic use of topical steroids can lead to significant adverse events [4][5] - ZORYVE cream formulations were well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 years and older and 2.5% of participants aged 2 to 5 [4][5] - The investigational ZORYVE cream 0.05% is currently under FDA review, with a target action date of October 13, 2025, indicating potential for future market introduction [13]