Roflumilast 0.05% Gains FDA Approval for Children 2-5 with AD

The US Food and Drug Administration (FDA) has approved roflumilast cream 0.05% (Zoryve®, Arcutis Biotherapeutics) for the treatment of mild-to-moderate atopic dermatitis (AD) in children 2 to 5 years old. This once-daily topical phosphodiesterase-4 (PDE4) inhibitor is the first steroid-free treatment in its class approved for this age group and is indicated for use on any area of the body, without duration limitations.

In clinical trials, including the Phase 3 INTEGUMENT-PED study, roflumilast cream 0.05% demonstrated rapid and meaningful improvements. At 4 weeks, approximately 40% of children achieved a 75% reduction from baseline in the Eczema Area and Severity Index (EASI), while 35% experienced clinically significant reduction in itch intensity.

“Young children often experience widespread atopic dermatitis, and while topical steroids have been the mainstay of treatment, 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 an investigator in the INTEGUMENT study. “Zoryve provides an effective, nonsteroidal option that improves both signs and symptoms rapidly in this vulnerable age group.”

Roflumilast cream 0.05% is steroid-free and does not contain ingredients known to impair the skin barrier, which is critical in treating AD in young children. The latest approval marks the sixth FDA nod for the Zoryve portfolio in just over 3 years. Arcutis expects to make the new formulation commercially available by the end of October 2025.