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]

Core Insights - Arcutis Biotherapeutics, Inc. will present two posters at the 2025 American Academy of Dermatology annual meeting, focusing on the safety and efficacy of roflumilast cream and foam in treating atopic dermatitis and psoriasis [1][2][3] Group 1: Clinical Trials and Data - The company will present data from two Phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2) that demonstrate the pooled safety and local tolerability of roflumilast cream 0.15% in adults and children with atopic dermatitis who had prior inadequate responses to topical treatments [2][5] - A second presentation will highlight significant improvements in patient-related outcomes with roflumilast foam 0.3% in individuals older than 12 years with psoriasis of the scalp and body [2][7] Group 2: Product Information - Roflumilast cream 0.3% is FDA-approved for the topical treatment of plaque psoriasis in patients aged 6 years and older, while roflumilast cream 0.15% is approved for mild to moderate atopic dermatitis in the same age group [6][9] - ZORYVE foam 0.3% is under FDA review for the treatment of scalp and body psoriasis, with a target action date of May 22, 2025 [8] Group 3: Educational Initiatives - Arcutis will support educational sessions on Culturally Conscious Dermatology™ at the conference, providing attendees with insights into culturally sensitive dermatological care [4]