FDA Accepts sNDA for Roflumilast Cream 0.05% in Infants With Atopic Dermatitis Down to 3 Months

The FDA has accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) seeking to expand its indication to include infants aged 3 months to younger than 2 years with mild to moderate atopic dermatitis (AD), according to a company announcement released today.¹ If approved, the indication would extend use of the once-daily topical phosphodiesterase-4 (PDE4) inhibitor to one of the youngest patient populations affected by AD.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 8, 2027, and the agency has indicated it is not currently planning to hold an advisory committee meeting to review the application.

INTEGUMENT-INFANT Data Support Submission

The sNDA is supported by data from the phase 2 INTEGUMENT-INFANT study and a phase 1 pharmacokinetic trial evaluating once-daily roflumilast cream 0.05% in infants aged 3 months to younger than 2 years with mild to moderate AD. At the time of the submission, Arcutis reported the program met its primary safety endpoint and demonstrated clinically meaningful improvements in disease severity and itch, with no new safety signals observed.

As previously reported by Dermatology Times, nearly half of treated infants (49.1%) achieved a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear at week 4, while 27.3% achieved vIGA-AD Success, defined as clear or almost clear skin with at least a 2-grade improvement from baseline. Investigators also observed rapid reductions in itch, with 35.7% of infants achieving a 4-point or greater improvement on the Worst Itch Numeric Scale by week 4.

The safety profile was consistent with previous studies of roflumilast cream in older pediatric populations. The most commonly reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting, with no unexpected safety findings reported.

"Receiving FDA acceptance of this application is an important milestone toward addressing a significant unmet need for infants living with atopic dermatitis and their families," Frank Watanabe, president and chief executive officer of Arcutis, said in a news release.¹

Potential to Expand Treatment Options

Roflumilast cream is a once-daily, steroid-free PDE4 inhibitor designed for long-term management of inflammatory skin diseases. The 0.05% formulation is currently approved for the topical treatment of mild to moderate AD in patients aged 2 years and older, while the 0.15% formulation is approved for patients aged 6 years and older.² The topical can be used on all affected skin areas, including sensitive and intertriginous sites, without restrictions on duration of use.

Commenting on the significance of the expanded pediatric indication, Dermatology Times Editor in Chief Christopher Bunick, MD, PhD, highlighted the unmet need for advanced nonsteroidal therapies in infants and toddlers.

"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. 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."

If approved, the expanded indication would provide dermatologists and pediatric clinicians with a nonsteroidal topical treatment option for infants as young as 3 months, a population with limited long-term therapeutic options.

Looking Ahead

Arcutis has continued to expand the pediatric indications for roflumilast across inflammatory skin diseases. Earlier this year, the FDA approved a supplemental New Drug Application for roflumilast cream 0.3% (Zoryve) to treat plaque psoriasis in children as young as 2 years of age, lowering the approved minimum age from 6 years.²

If the current application is approved, roflumilast cream 0.05% would similarly become available for an even younger patient population, expanding use in infants with AD down to 3 months of age. The successive regulatory milestones underscore an ongoing effort to address treatment gaps for infants and young children with chronic inflammatory skin diseases, populations with historically limited nonsteroidal topical treatment options.

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