Arcutis Biotherapeutics, Inc. (ARQT) announced on Wednesday promising outcomes from the INTEGUMENT-open label extension long-term study. This study evaluated the efficacy of once-daily roflumilast cream 0.05% in treating mild to moderate Atopic Dermatitis (AD) in children aged 2 to 5 years.The study highlighted sustained efficacy and a favorable safety profile for the therapy. After 56 weeks, INTEGUMENT-PED reported a 75% improvement from baseline in the Eczema Area and Severity Index.The Phase 3 trial of roflumilast cream 0.05% initially demonstrated rapid efficacy within the first four weeks of treatment and confirmed its long-term effectiveness and tolerability.Arcutis plans to submit a supplemental New Drug Application (sNDA) to the FDA in the first quarter of 2025 for the use of roflumilast cream 0.05% in treating AD in children aged 2-5 years.The material has been provided by InstaForex Company – www.instaforex.com
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