FDA Approves Zoryve Cream for Treating Atopic Dermatitis in Young Children

The U.S. Food and Drug Administration (FDA) has granted approval for Zoryve (roflumilast) cream 0.05% as a topical treatment for children aged 2 to 5 years with mild-to-moderate atopic dermatitis. This approval marks a significant advancement in pediatric eczema management, offering a non-steroid option that can be applied once daily over any area of the body. The decision was based on clinical trial data demonstrating that Zoryve swiftly reduced the severity and extent of eczema symptoms. Approximately 40% of pediatric participants achieved a 75% improvement in eczema severity scores, and over one-third (35%) experienced meaningful relief from itching within four weeks.

Young children are particularly susceptible to the discomfort caused by atopic dermatitis due to their underdeveloped immune systems and skin barriers, which can result in ongoing skin issues and reduced quality of life. As Korey Capozza, founder and executive director at Global Parents of Eczema Research, explained, this condition impacts not just the child's skin but also affects family dynamics through sleep disturbances, emotional stress, and social challenges.

The approval was granted to Arcutis Biotherapeutics and provides families with a new therapeutic option that avoids the use of steroids, which are traditionally employed in eczema treatment. Overall, Zoryve’s approval is a promising step forward in the management of pediatric atopic dermatitis, aiming to improve the comfort and well-being of young children affected by this chronic condition.

Source: https://medicalxpress.com/news/2025-10-fda-zoryve-atopic-dermatitis-young.html