Arcutis Submits sNDA for Roflumilast Cream 0.05% to Treat Atopic Dermatitis in Infants

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration seeking to expand the indication for topical roflumilast cream 0.05% (ZORYVE) to include infants as young as 3 months with mild to moderate atopic dermatitis (AD).¹

“This sNDA submission represents an important milestone in our effort to expand treatment options for infants as young as 3 months living with atopic dermatitis, an age group with very limited treatment options today,” said Frank Watanabe, president and CEO of Arcutis. “If approved, investigational ZORYVE cream 0.05% could offer an effective and well-tolerated treatment option suitable for long-term use, helping infants and their families maintain clear skin and limit cumulative topical steroid exposure. This potential age expansion supports our strategy to broaden ZORYVE’s reach and reinforces its role as a foundational therapy across age groups.”¹

Supporting Clinical Trial Insights

The INTEGUMENT-INFANT trial enrolled 101 infants aged 3 months to younger than 24 months with mild to moderate disease and evaluated treatment over 4 weeks.² Investigators reported that once-daily roflumilast was well tolerated, with a safety profile consistent with findings from previous pediatric studies in older children. The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting, with no unexpected safety signals identified.

Efficacy outcomes from the study demonstrated clinically meaningful improvements across investigator-assessed and caregiver-reported endpoints. Among infants completing 4 weeks of therapy, 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, defined as clear or almost clear skin with at least a two-grade improvement from baseline. Additionally, 49% achieved clear or almost clear skin by week 4, with responses evident as early as week 2 and improvements observed beginning in week 1.

Prioritizing Symptomatic Relief and Itch Reduction

Measures of disease severity also supported therapeutic activity. More than half of treated infants achieved EASI-75 by week 4, while approximately one-third reached this threshold by week 2, suggesting a relatively rapid onset of improvement. Notably, among infants with scalp involvement at baseline, two-thirds achieved vIGA-scalp success at week 4, a finding that may be of interest given the management challenges associated with scalp disease in infants.

Pruritus reduction, a central treatment priority in pediatric AD, also emerged as a notable finding. Caregiver-reported assessments indicated rapid itch improvement, with responses seen as early as 10 minutes in some infants based on Dynamic Pruritus Scale measures. By week 4, nearly three-quarters of evaluable patients achieved Worst Scratch Itch Numeric Rating Scale success, further supporting potential symptomatic benefit.

Addressing Unmet Needs in Pediatric Care

Supporting the application, the phase 1 pharmacokinetic study in 19 infants demonstrated systemic exposure, safety, and efficacy findings aligned with prior pediatric experience, adding reassurance regarding use in very young patients. Importantly, the 0.05% formulation was specifically designed for younger children, with consideration of age-related skin barrier characteristics and the need for a tolerable vehicle suitable for sensitive areas such as the face and skin folds.

“Atopic dermatitis often begins within the first year of life, yet treatment options for infants are extremely limited. Parents and caregivers are often faced with difficult decisions around managing these symptoms, including concerns about the long-term use of topical steroids,” Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC, and INTEGUMENT-INFANT clinical trial investigator, said. “Because their immune system and skin barrier are still developing, infants are particularly vulnerable to the burdensome symptoms of atopic dermatitis, including visible disease and intense itch that can disrupt sleep and significantly impact both infants and their caregivers. Safe and effective long-term therapies suitable for use anywhere on the body, including sensitive regions such as the face and skin folds, remain an important unmet need for infants with atopic dermatitis. If approved, ZORYVE cream 0.05% could offer a much-needed, non-steroidal treatment option developed specifically for very young children, including infants.”¹

If approved, the age expansion would provide one of few nonsteroidal anti-inflammatory therapies specifically indicated for infants with atopic dermatitis and could help address longstanding gaps in care at a stage when disease burden, caregiver concern, and the potential value of early intervention are especially pronounced. In October 2025, roflumilast was approved for AD in children aged 2 to 5 years.³

References

1. Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months. News release. Arcutis. April 27, 2026. Accessed April 27, 2026. https://www.arcutis.com/arcutis-submits-supplemental-new-drug-application-to-the-fda-for-zoryve-roflumilast-cream-0-05-to-expand-indication-for-treatment-of-atopic-dermatitis-to-infants-down-to-3-months/

2. Eichenfield L. INTEGUMENT-INFANT: once-daily roflumilast cream 0.05% in infants aged 3–<24 months with atopic dermatitis. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.

3. FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. Arcutis. October 6, 2025. Accessed April 27, 2026. 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