FDA accepts Arcutis’ sNDA for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis. Phase 2 data support the filing, with a PDUFA decision expected on February 23, 2027.
Written By: Amit Kumar Bharati, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05% from Arcutis Biotherapeutics to expand its indication for the treatment of mild-to-moderate atopic dermatitis to infants aged 3 to 24 months. The agency assigned a Prescription Drug User Fee Act target action date of February 23, 2027.
If approved, ZORYVE cream 0.05% would become the first once-daily targeted non-steroidal topical therapy specifically approved for infants with atopic dermatitis. The filing addresses a significant treatment gap for this age group, where therapeutic options remain limited because of concerns surrounding prolonged topical corticosteroid use during early skin and immune system development.
Approximately 1 million children younger than two years receive topical treatment for atopic dermatitis each year in the United States, representing nearly 10% of all patients treated topically for the disease.
A targeted PDE4 inhibitor for chronic inflammatory skin disease
Roflumilast is a topical phosphodiesterase-4 (PDE4) inhibitor that suppresses inflammatory signaling by reducing the production of pro-inflammatory mediators. The once-daily cream formulation is steroid-free, non-greasy, and formulated without common sensitizing ingredients such as propylene glycol, polyethylene glycol, ethanol, or fragrances.
ZORYVE cream 0.05% is already approved in the United States for children aged 2 to 5 years with mild-to-moderate atopic dermatitis.
Clinical studies showed rapid disease improvement and favorable safety
The sNDA is supported by data from the Phase 2 open-label INTEGUMENT-INFANT study (NCT06998056) and a Phase 1 open-label pharmacokinetic study, which evaluated once-daily ZORYVE cream 0.05% in infants aged 3 months to younger than 24 months.
The INTEGUMENT-INFANT trial enrolled 101 infants and assessed safety, tolerability, and exploratory efficacy over four weeks, while the Phase 1 pharmacokinetic study included 19 infants. Both studies demonstrated pharmacokinetic, efficacy, and safety profiles consistent with previous trials in children aged 2 to 5 years.
Among the 96 infants who completed four weeks of treatment, 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.
Disease severity also improved substantially, with 58.3% of infants achieving EASI-75 by Week 4 and 34% reaching EASI-75 by Week 2. Among infants with scalp involvement at baseline, 67.5% achieved vIGA-scalp success after four weeks of treatment.
Caregivers also reported rapid itch relief. Nearly 46.6% of infants experienced at least a 25% reduction in itch within 10 minutes of application, based on the caregiver-assessed Dynamic Pruritus Scale.
Treatment was generally well tolerated, with no new safety signals identified during the four-week studies. The most commonly reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting.
Expanding treatment options for the youngest patients
Clinical investigator Lawrence F. Eichenfield, MD, noted that infants with atopic dermatitis often experience severe itching, sleep disruption, and widespread skin involvement, creating substantial challenges for both children and caregivers. He said an effective steroid-free therapy suitable for prolonged use on sensitive areas such as the face and skin folds would address an important unmet clinical need.
Arcutis President and CEO Frank Watanabe said the FDA’s acceptance highlights the continued need for additional treatment options in very young children. He added that, if approved, ZORYVE cream 0.05% could extend the therapy’s use from infancy through adulthood while providing clinicians with a once-daily targeted alternative to topical steroids.
The FDA is expected to complete its review by February 23, 2027. A positive decision would further expand the ZORYVE franchise across inflammatory skin diseases while providing infants with a new non-steroidal treatment option for chronic atopic dermatitis.
Reference
About the Writer
Amit Kumar Bharti (LinkedIn) is a pharmacy graduate from DPSRU, Delhi and healthcare writer with a strong interest in pharmaceutical research, medical writing, and evidence-based healthcare communication. He is passionate about translating complex scientific and medical information into clear, accurate, and engaging content for healthcare professionals and the pharmaceutical industry. His focus includes emerging therapies, clinical research, and recent advances in medicine.