WESTLAKE VILLAGE, Calif., July 8, 2026
Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval of ZORYVE® (roflumilast) cream 0.05% for the treatment of mild to moderate atopic dermatitis in infants aged 3 to 24 months. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027. If approved, ZORYVE cream 0.05% would become the first once-daily advanced targeted steroid-free topical therapy specifically indicated for this vulnerable patient population. The application is supported by positive clinical findings from the Phase 2 open-label INTEGUMENT-INFANT study and a Phase 1 pharmacokinetic (PK) study, addressing a significant unmet need for safe and effective long-term treatment options for infants with eczema. Approximately one million children under the age of two receive topical treatment for atopic dermatitis in the United States, highlighting the substantial clinical importance of expanding treatment choices.
Clinical Studies Demonstrate Strong Safety Profile and Rapid Symptom Improvement
The sNDA is supported by data from the INTEGUMENT-INFANT trial, which enrolled 101 infants with mild to moderate atopic dermatitis, along with a Phase 1 PK study involving 19 infants aged between 3 months and less than 24 months. Across both studies, ZORYVE cream 0.05% demonstrated a well-tolerated safety profile with no new safety signals identified during four weeks of once-daily treatment. The most commonly reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting, consistent with previous pediatric studies. Clinically, the investigational therapy produced rapid improvements in disease severity, with 34.4% of infants achieving Validated Investigator Global Assessment (vIGA-AD) success after four weeks. Additionally, 58.3% achieved at least a 75% reduction in Eczema Area and Severity Index (EASI-75) by Week 4, while 34% reached the same milestone by Week 2. Among infants with scalp involvement, 67.5% achieved vIGA-scalp success, and caregivers reported rapid itch relief, with 46.6% of infants showing measurable improvement within just 10 minutes following application.
Steroid-Free Once-Daily Therapy Addresses Major Pediatric Treatment Gap
Atopic dermatitis is the most common form of eczema and frequently develops during infancy, causing persistent itching, skin inflammation, sleep disruption, and considerable emotional and physical stress for both children and caregivers. Experts note that treatment options for infants remain limited because of concerns surrounding prolonged use of topical corticosteroids, particularly on sensitive areas such as the face, neck, and skin folds. ZORYVE cream 0.05%, a topical phosphodiesterase-4 (PDE4) inhibitor, provides a once-daily, steroid-free, non-greasy formulation that does not contain common irritants such as propylene glycol, polyethylene glycol, ethanol, or fragrances. According to clinical investigators, the therapy has the potential to offer physicians and caregivers an important new long-term treatment option that can be safely used across all body areas while effectively reducing inflammation and itch.
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Expanded Indication Could Strengthen ZORYVE’s Dermatology Leadership
ZORYVE has established itself as the leading branded topical therapy across atopic dermatitis, plaque psoriasis, and seborrheic dermatitis, supported by multiple FDA approvals and strong recognition within the dermatology community. The product portfolio currently includes ZORYVE cream 0.05% for children aged 2 to 5 years, ZORYVE cream 0.15% for patients 6 years and older, and ZORYVE cream and foam 0.3% for plaque psoriasis and seborrheic dermatitis. Approval of this expanded indication would extend the therapy’s use from infancy through adulthood, reinforcing Arcutis’ strategy of providing innovative steroid-free immuno-dermatology treatments across all age groups. With the FDA’s February 2027 review deadline, the company is positioned to potentially deliver a significant advancement in pediatric dermatology by addressing one of the largest remaining unmet needs in the treatment of infant atopic dermatitis.
Source: Arcutis Biotherapeutics press release
