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FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well toleratedOnce-daily,
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well toleratedOnce-daily, steroid-free cream can be used anywhere on the body for any durationAbout 1.8 million children ages 2 to 5 with atopic dermatitis are topically treated in the U.S.Sixth FDA approval for ZORYVE in just over three yearsCommercial product expected to be available by the end of October 2025 WESTLAKE VILLAGE, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. Once-daily ZORYVE cream 0.05% provides rapid and significant clearance of atopic dermatitis anywhere on the body and offers clinicians, parents, and caregivers of children ages 2 to 5 an alternative to steroids that can be used for any duration. “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime. Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use,” said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and INTEGUMENT study investigator. \"In clinical trials, ZORYVE cream 0.05% rapidly improved the severity and extent of eczema (atopic dermatitis) signs and symptoms, with approximately 40% of children achieving a 75% improvement from baseline as measured by EASI, and more than one-third (35%) achieving a clinically meaningful improvement in itch intensity, both in only four weeks. With this approval, healthcare providers and families have an effective new treatment option for young children with atopic dermatitis.” In the United States, approximately 1.8 million children between the ages of 2 to 5 with atopic dermatitis are treated with a topical product. Itch is one of the mos...