Arcutis Biotherapeutics Inc. (NASDAQ: ARQT) submitted a supplemental new drug application to the FDA seeking to expand the indication for ZORYVE cream 0.05% to include treatment of mild to moderate atopic dermatitis in infants as young as 3 months old.

The application is supported by data from the INTEGUMENT-INFANT Phase 2 open-label study involving infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The study enrolled 101 infants and assessed safety, tolerability, and efficacy over four weeks.

Among the 96 infants who completed four weeks of treatment, 34.4% achieved success on the Validated Investigator Global Assessment for Atopic Dermatitis, defined as a score of Clear or Almost Clear with at least a 2-grade improvement from baseline. Additionally, 49% of infants achieved a Clear or Almost Clear score at Week 4.

The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. The safety profile was consistent with prior studies in older children and adults.

ZORYVE cream was well tolerated with a safety and tolerability profile consistent with prior pediatric experience. The treatment showed 58.3% of infants achieved at least a 75% reduction in Eczema Area and Severity Index at Week 4.

Atopic dermatitis affects approximately 1 million children under age 2 in the United States, with limited treatment options available for infants. Currently, only one other FDA-approved topical non-steroidal anti-inflammatory agent is available for this age group.

ZORYVE cream 0.05% is currently approved for treatment of mild to moderate atopic dermatitis in patients aged 2-5 years. The company states the 0.05% dose was specifically selected for children 5 years and younger based on understanding of skin barrier dysfunction in atopic dermatitis.