Arcutis Biotherapeutics(ARQT) Newsfilter·2024-12-16 13:00Core Message - ZORYVE cream 0.05% demonstrated meaningful disease clearance and rapid itch reduction in pivotal trials, with a favorable safety profile for up to 56 weeks of treatment [1] - The sNDA submission for ZORYVE cream 0.05% targets mild to moderate atopic dermatitis (AD) in children aged 2 to 5, addressing a significant unmet need in pediatric dermatology [1][2] Clinical Trial Results - In the INTEGUMENT-PED Phase 3 trial, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success at Week 4, compared to 10.7% in the vehicle group (P<0.0001) [3] - Significant improvements in itch reduction were observed as early as Week 1, with 35.3% of children achieving a four-point reduction in WI-NRS at Week 4 (vs. 18.0% for vehicle-treated children) [3] - The safety profile in 2- to 5-year-old pediatric subjects was consistent with that observed in adults and older pediatric subjects, with mild adverse events such as upper respiratory tract infection, diarrhea, and vomiting [4] Market and Patient Population - Approximately 1.8 million children aged 2 to 5 in the United States are topically treated for atopic dermatitis, highlighting the potential market size for ZORYVE cream 0.05% [1] - Pediatric AD significantly impacts the quality of life for both children and their caregivers, emphasizing the need for effective and safe treatment options [2] Company and Product Background - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on immuno-dermatology, with a growing portfolio of FDA-approved products [11] - ZORYVE cream 0.3% is approved for plaque psoriasis in patients aged 6 and older, while ZORYVE cream 0.15% is approved for mild to moderate AD in the same age group [6][7] - The company’s dermatology development platform includes multiple clinical programs targeting inflammatory dermatological conditions such as psoriasis, AD, and alopecia areata [11]