FDA Approves Arcutis’ ZORYVE® Cream 0.05% For Treating Mild To Moderate Atopic Dermatitis In Children Aged 2–5

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company focused on innovative treatments in immuno-dermatology, 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 aged 2 to 5 years. The once-daily cream provides rapid and meaningful improvement of atopic dermatitis symptoms anywhere on the body and offers a non-steroidal treatment option suitable for long-term use, giving clinicians, parents, and caregivers an effective alternative to topical steroids.

Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and INTEGUMENT study investigator, highlighted the importance of safe treatments for young children, who often experience widespread disease at an early age. He noted that in clinical trials, ZORYVE cream 0.05% led to rapid improvement, with around 40% of children achieving a 75% reduction in eczema severity (as measured by EASI) and over one-third experiencing meaningful relief from itch within four weeks. This approval provides healthcare providers and families with a much-needed treatment option for young children with atopic dermatitis.

Atopic dermatitis affects approximately 1.8 million children aged 2 to 5 in the United States, with itch being one of the most challenging and disruptive symptoms. Korey Capozza, MPH, founder and executive director at Global Parents of Eczema Research, emphasized that young children are particularly vulnerable because their immune systems and skin barriers are still developing. He explained that the condition affects not only the child but also the family, causing sleep disruption, emotional stress, and social challenges.

Frank Watanabe, president and CEO of Arcutis, noted that ZORYVE cream was specifically formulated to address unmet needs in pediatric atopic dermatitis care. Unlike topical steroids, ZORYVE targets underlying inflammation without including ingredients that can compromise the skin barrier, making it suitable for long-term use. Watanabe emphasized that the therapy helps maintain clear skin and reduces cumulative exposure to steroids.

The real-world impact of ZORYVE is illustrated by the experience of Melissa Walters, whose daughter Kylie participated in the clinical trials. She shared that before treatment, Kylie struggled with discomfort and disrupted sleep, affecting the entire family. After using ZORYVE cream in the study, Kylie’s skin improved significantly, demonstrating the benefits of a treatment that can be safely used over the long term.

This latest approval marks the sixth FDA approval for the ZORYVE portfolio in just over three years. Arcutis plans to make ZORYVE cream 0.05% widely available through key wholesalers and pharmacy channels by the end of October 2025. The company is committed to ensuring predictable access through patient support programs. The ZORYVE Direct Program helps patients navigate insurance coverage, supports adherence, and offers the ZORYVE Direct Savings Card to reduce out-of-pocket costs for eligible commercially insured patients. Additionally, the Arcutis Cares™ patient assistance program provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.