FDA Accepts sNDA for Roflumilast Cream 0.05% in Infants With AD

The US Food and Drug Administration (FDA) anounced that it has accepted Arcutis Biotherapeutics' supplemental New Drug Application (sNDA) seeking to expand the indication for ZORYVE (roflumilast) cream 0.05% to include infants aged 3 to 24 months with mild to moderate atopic dermatitis (AD)

The application was supported by data from the Phase 2 open-label INTEGUMENT-INFANT trial and a Phase 1 open-label pharmacokinetic study evaluating once-daily roflumilast cream 0.05% in infants younger than 2 years. Together, the studies enrolled 120 infants and demonstrated pharmacokinetic, safety, and exploratory efficacy findings that were consistent with previous studies in children aged 2 to 5 years, according to the company.

Study Data Support Potential Expanded Pediatric Indication

The INTEGUMENT-INFANT study enrolled 101 infants and evaluated treatment over 4 weeks. Among the 96 infants who completed treatment, 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success, defined as a score of Clear or Almost Clear with at least a 2-grade improvement from baseline. Additionally, 58.3% achieved at least a 75% improvement in Eczema Area and Severity Index (EASI-75) by Week 4, with 34% reaching EASI-75 as early as Week 2.

Among infants with baseline scalp involvement, 67.5% achieved vIGA-scalp success at Week 4. Caregiver-reported itch also improved rapidly, with 46.6% of infants achieving at least a 25% reduction in pruritus within 10 minutes of application as measured by the Dynamic Pruritus Scale.

There were no new safety signals. The most commonly reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting.

ZORYVE cream 0.05% is a once-daily, steroid-free topical phosphodiesterase-4 inhibitor currently approved in the United States for mild to moderate atopic dermatitis in children aged 2 to 5 years. According to Arcutis, approximately 1 million children younger than 2 years receive topical treatment for atopic dermatitis annually in the United States. If approved, the expanded indication would extend treatment eligibility to infants as young as 3 months.

“Infants with atopic dermatitis are particularly vulnerable to burdensome symptoms such as intense itch and sleep disruption, which can impact the whole family. Managing these symptoms can be particularly challenging for parents and caregivers due to the very limited FDA-approved treatment options as well as concerns about the use of topical steroids on infants whose skin barrier and immune system are still developing,” said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital San Diego and the University of California San Diego School of Medicine and an INTEGUMENT-INFANT clinical trial investigator, said in a press release. “There is a significant unmet need in this population for therapies that can be used anywhere on the body for any duration of time, including on sensitive areas such as the face and skin folds. If approved, ZORYVE cream 0.05% could provide clinicians and caregivers with an important new steroid-free treatment option that was specifically developed for infants and very young children.”

Source

Arcutis Biotherapeutics press release, July 8, 2026.