FDA approves roflumilast cream 0.05% for atopic dermatitis for children aged 2 to 5 years

On Monday, October 6, the FDA approved roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) to treat atopic dermatitis (AD) in children aged 2 to 5 years. According to a press release from Arcutis, the topical, nonsteroidal phosphodiesterase 4 inhibitor can be used anywhere on the body for any duration.¹

The decision comes ahead of the scheduled October 13, 2025, target action date set by the FDA, following the federal agency's acceptance of the supplemental new drug application on February 26, 2025.²

"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," said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and INTEGUMENT study investigator, in a statement. "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."¹

Top-line data that led to the approval of roflumilast cream 0.05%

The approval of roflumilast cream 0.05% was based on results from the phase 3 INTEGUMENT-PED trial, the INTEGUMENT-OLE long-term extension study (NCT04804605), and a phase 1 pharmacokinetic study.

In INTEGUMENT-PED, roflumilast achieved rapid disease clearance, with significant improvement seen as early as week 1. By week 4, 25.4% of children treated with roflumilast reached Validated Investigator Global Assessment for Atopic Dermatitis success—defined as “clear” or “almost clear” skin with at least a 2-grade improvement from baseline—compared with 10.7% using vehicle (P < .0001).

Roflumilast also improved itch and overall disease severity, with 39.4% having achieved Eczema Area and Severity Index of 75% or greater improvement (EASI-75) at week 4 compared with 20% with vehicle, with over one-third of caregivers having reported a 4-point or greater reduction in itch scores (vs 18% with vehicle). Adverse events were mostly mild and included upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache.

WATCH: Key atopic dermatitis approvals are changing the treatment landscape

In the INTEGUMENT-OLE extension, efficacy was maintained and enhanced over 56 weeks. Nearly 72% of participants from the pediatric trial achieved EASI-75 after long-term treatment, and those who transitioned to proactive twice-weekly dosing maintained disease control for a median of 238 days. Safety remained consistent with the pivotal trials.

AD affects an estimated 9.6 million US children and typically appears before the age of 5 years. For this population, roflumilast offers a topical, nonsteroidal option that demonstrated both durability and early onset of action in young children.

"With this approval, health care providers and families have an effective new treatment option for young children with atopic dermatitis," added Eichenfield.

Other roflumilast coverage on Contemporary Pediatrics

• Roflumilast foam 0.3% is approved to treat plaque psoriasis of the scalp and body in adults and pediatric patients 12 years or older. Click here for more on this indication, which was approved by the FDA on May 22, 2025.
• Roflumilast foam 0.3% is approved to treat seborrheic dermatitis in adults and pediatric patients 9 years or older. Click here for more on this indication, which was approved by the FDA on December 15, 2025.
• Roflumilast cream 0.3% is approved for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years or older. Click here for more on this indication, which was approved by the FDA on October 9, 2023.
• Roflumilast cream 0.15% is approved to treat mild to moderate AD in adult and pediatric patients 6 years or older. Click here for more on this indication, which was approved by the FDA on July 9, 2024.

This article will be updated shortly.

References

1. FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. Press release. Arcutis Biotherapeutics. October 6, 2025. Accessed October 6, 2025. https://www.globenewswire.com/news-release/2025/10/06/3161656/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-05-for-the-Treatment-of-Atopic-Dermatitis-in-Children-Ages-2-to-5.html
2. Fitch J. FDA accepts roflumilast cream 0.05% sNDA for children with atopic dermatitis. Contemporary Pediatrics. February 26, 2025. Accessed October 6, 2025. https://www.contemporarypediatrics.com/view/fda-accepts-roflumilast-cream-0-05-snda-in-children-with-atopic-dermatitis