Roflumilast Cream 0.05% sNDA Submitted to FDA for Infants Down to 3 Months with Atopic Dermatitis

A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration (FDA) for the broadening of roflumilast cream 0.05% (Zoryve) to treat mild to moderate atopic dermatitis in infants down to the age of 3 months.1

The sNDA submission, announced on April 27 by Arcutis Biotherapeutics, was backed by data from a pair of open-label studies assessing once-daily roflumilast cream 0.05% in infants aged 3 to less than 24 months with mild to moderate atopic dermatitis. The disease itself is the most prevalent form of eczema in the US, impacting an estimated 9.6 million children and 16.5 million adults.

“Atopic dermatitis often begins within the first year of life, yet treatment options for infants are extremely limited,” Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC and INTEGUMENT-INFANT clinical trial investigator, said in a statement.1 “Parents and caregivers are often faced with difficult decisions around managing these symptoms, including concerns about the long-term use of topical steroids. 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.”

The disease often manifests during infancy, imposing considerable burden on both patients and their caregivers. The disease presents unique treatment considerations among infants, including a higher body surface area-to-body mass ratio heightening systemic exposure risk from topical medications.

The data leading to this sNDA first included a phase 1 pharmacokinetic study in 19 infants demonstrating a safety, efficacy, and pharmacokinetic profile over 4 weeks. These findings aligned with data from prior research in older pediatric populations. In the larger phase 2 INTEGUMENT-INFANT trial, 101 infants were recruited and roflumilast cream’s safety, tolerability, and efficacy were evaluated across 4 weeks of treatment.

The medication was shown by Gonzalez and colleagues to be well tolerated, with patients’ most commonly reported adverse events (AEs) being nasopharyngitis, diarrhea, upper respiratory tract infection, and vomiting.1 These AEs were described as consistent with the broader INTEGUMENT program experience.

In the infants completing the full 4-week treatment course (n=96), investigators found 34.4% attained success in their Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, defined as a ‘clear’ or ‘almost clear’ score with at least a 2-grade improvement from baseline.1 The team further noted 49% succeeded in achieving a vIGA-AD score at the 4-week mark.

Improvements were observed by Gonzalez et al as early as Week 1. Among infants showing scalp involvement at baseline, 67.5% saw vIGA-scalp success at the 4-week mark, and 58.3% attained an EASI-75 score at Week 4.1 The team further noted notable caregiver-reported itch outcomes, including that 72.7% of infants met the threshold for Worst Scratch Itch Numeric Rating Scale success at Week 4. Rapid onset was observed in these infants, as suggested by a 46.6% response rate on the Dynamic Pruritus Scale by 10 minutes post-application.

Roflumilast cream 0.05% is already FDA-approved for mild to moderate AD in patients aged 2 to 5 years.2 This new move could expand its indication if it receives approval by FDA officials for this newer age range.

“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,” Gonzalez said in her statement.1 “If approved, [roflumilast] cream 0.05% could offer a much-needed, non-steroidal treatment option developed specifically for very young children, including infants.”

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. Arcutis Biotherapeutics, Inc. April 27, 2026. https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-supplemental-new-drug-application-fda-zoryver.

2. Smith T. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. October 6, 2025. Accessed April 27, 2026. https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years.