The FDA has approved roflumilast (Zoryve, Arcutis), a once-daily, steroid-free cream for the topical treatment of mild-to-moderate atopic dermatitis (AD) in children aged 2 to 5 years. This approval marks a significant advancement in pediatric AD management, offering clinicians and caregivers a steroid-free option that can be used safely for any duration and on any area of the body.
Efficacy and Safety
Roflumilast is a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation by blocking the release of pro-inflammatory cytokines. Because AD is driven by immune dysregulation and barrier impairment, it often appears early in life, which is why roflumilast 0.05% was specifically formulated to address the signs and symptoms of pediatric disease while maintaining a favorable safety profile.
According to Arcutis president and CEO, Frank Watanabe, roflumilast “provides patients and their families with a treatment option for long-term, continuous use, helping maintain clear skin and limiting cumulative topical steroid exposure.”
Clinical Results
The approval is based on results from phase 3 trials demonstrating:
- Rapid improvement in AD severity, with approximately 40% of children achieving at least a 75% improvement from baseline within 4 weeks.
- Clinically meaningful improvement in itch intensity for 35% of patients by week 4.
- Favorable tolerability with minimal local irritation, including in sensitive areas such as the face and neck.
Ongoing Relief for Patients and Their Families
An estimated 1.8 million children in the U.S. aged 2 to 5 years receive topical treatment for AD, a chronic inflammatory disorder that can significantly disrupt sleep and quality of life for both patients and families.
“This condition doesn’t just affect the child’s skin,” said Korey Capozza, MPH, founder and executive director at Global Parents of Eczema Research. “It can affect the whole family by causing sleep disruption, emotional distress, and social isolation.”
Roflumilast offers a long-term, steroid-free option that targets the inflammation driving AD without ingredients known to compromise the skin barrier — supporting both disease control and caregiver peace of mind.
Expansion and Future Impact
This approval marks the sixth FDA authorization for roflumilast in just over three years. Arcutis has also submitted a supplemental NDA for roflumilast cream 0.3% to treat plaque psoriasis in children aged 2 years and older.
“Psoriasis in kids is on the rise, yet our treatment strategies for kids in preschool have not changed in decades,” said Lisa Swanson, MD, FAAD, pediatric dermatologist at Ada West Dermatology in Boise, Idaho. “We need more options to treat plaque psoriasis in pediatric patients, and we need them to be steroid-free, so I am so excited to see Arcutis pursue studies and indications for our littlest psoriasis patients.”
Arcutis plans to make roflumilast 0.05% widely available through wholesalers and pharmacies in the U.S. by late October 2025. The company’s Zoryve Direct program will help families navigate insurance coverage and provide copay savings for eligible patients. For uninsured or underinsured individuals, the Arcutis Cares patient assistance program offers the medication at no cost.
New Options in Care
As pediatric AD management evolves toward safer and more targeted therapies, roflumilast offers clinicians a valuable addition to the treatment armamentarium — bridging the gap between conventional steroids and newer systemic biologics. For young patients and their families, it represents a well-tolerated, long-term solution that supports both disease control and quality of life.
