Key takeaways:
- FDA approved roflumilast cream 0.05% (Zoryve) for children aged 2–5 years with atopic dermatitis—offering a nonsteroidal, bodywide treatment option.
- Approval was backed by phase 3 INTEGUMENT-PED data, showing rapid clearance and significant itch reduction by week 4, with durable results in long-term follow-up.
- “It is essential to have safe and effective treatments for children,” said Lawrence F. Eichenfield, MD, noting that topical steroids “are not appropriate for long-term use.”
On Monday, October 6, the FDA approved roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) to treat atopic dermatitis in children aged 2 to 5 years. According to a press release from Arcutis, the topical, non-steroidal, phosphodiesterase 4 (PDE4) 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, this year.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
Topline 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 vIGA-AD success—defined as “clear” or “almost clear” skin with at least a 2-grade improvement from baseline—compared with 10.7% using vehicle (P < 0.0001).
Roflumilast also improved itch and overall disease severity, with 39.4% having achieved EASI-75 at week 4 compared to 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.
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.
Atopic dermatitis affects an estimated 9.6 million US children and typically appears before age 5. For this population, roflumilast offers a topical, nonsteroidal option that demonstrated both durability and early onset of action in young children.
"With this approval, healthcare 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:
- FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5. Arcutis Biotherapeutics. Press release. 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
- 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
