On October 6, 2025, Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration approved the supplemental new drug application for ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children ages 2 to 5. The approval follows a robust clinical program, including the INTEGUMENT‑PED Phase 3 trial, and represents the sixth FDA approval for the ZORYVE portfolio.
Clinical data from the INTEGUMENT‑PED study showed that 39.4% of children achieved a 75% reduction in Eczema Area and Severity Index (EASI‑75) after four weeks, and 35% experienced a clinically meaningful reduction in itch intensity. The approval covers an estimated 1.8 million children in the United States, providing a new steroid‑free treatment option for a population that currently relies heavily on topical steroids.
This regulatory milestone expands Arcutis’s product line and strengthens its position in the pediatric dermatology market. The company plans to make the cream widely available through key wholesaler and pharmacy channels by the end of October 2025, supported by a unified copay card and patient assistance program to facilitate access for eligible patients.
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