Potential Steroid-Free Option Could Expand Atopic Dermatitis Treatment in Infants

Treating atopic dermatitis in infants can be challenging, especially because treatment options are limited and long-term corticosteroid use may not always be ideal. A potential new steroid-free therapy may soon become available for the youngest patients, as the FDA has accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) for the treatment of mild to moderate atopic dermatitis in infants aged 3 months to younger than 2 years.

If approved, the once-daily topical phosphodiesterase 4 (PDE4) inhibitor would expand the current indication for children aged 2 to 5 years to include infants as young as 3 months. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027.

Data Supporting the Application

The sNDA is supported by findings from the phase 3 INTEGUMENT-INFANT trial, which evaluated once-daily roflumilast cream 0.05% in infants with mild to moderate atopic dermatitis involving at least 3% body surface area.

The phase 3 INTEGUMENT-INFANT trial met its primary end point, demonstrating favorable safety and tolerability. Investigators also reported improvements in disease severity, itch, sleep disturbance, and caregiver-reported quality of life. No new safety signals were identified, and systemic absorption remained low, consistent with previous studies of topical roflumilast.

Why It Matters for Practice

Infants with atopic dermatitis have relatively few FDA-approved nonsteroidal treatment options. If approved, roflumilast cream 0.05% would provide clinicians with another once-daily steroid-free therapy for managing mild to moderate disease in this young population.

"Children 3 to 24 months of age have very limited options when it comes to treating their atopic dermatitis with an FDA-approved advanced non-steroidal therapy, regardless of whether that therapy is topical or systemic," said Christopher Bunick, MD, PhD, editor in chief of Dermatology Times. "News that roflumilast 0.05% cream is on track at the FDA, through the recent acceptance of the supplemental NDA application, for approval in this atopic dermatitis population is evidence that potent PDE4 inhibition is effective, safe, and tolerable. Roflumilast continues to impact dermatology patients and providers through its multiple indications and through its use in infants to adults."

The FDA is expected to make its decision by February 23, 2027.

References

1. FDA accepts supplemental new drug application for Arcutis' Zoryve (roflumilast) cream 0.05% for the treatment of mild to moderate atopic dermatitis in infants down to 3 months. News release. Arcutis Biotherapeutics. July 8, 2026. Accessed July 8, 2026. https://www.globenewswire.com/news-release/2026/07/08/3324020/0/en/fda-accepts-supplemental-new-drug-application-for-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-mild-to-moderate-atopic-dermatitis-in-infants-down-to-3-months.html
2. FDA approves Arcutis' Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. Arcutis Biotherapeutics. October 6, 2025. Accessed July 8, 2026. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-005-treatment