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# FDA OKs Arcutis’ Zoryve for Pediatric Eczema
- URL: https://www.fdaweb.com/fda-oks-arcutis-zoryve-for-pediatric-eczema/
- Published: 2025-10-06T12:00:00.000Z
- Updated: 2026-09-14T15:23:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159993

FDA has approved an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children ages 2 to 5, expanding access to the company’s once-daily, steroid-free topical therapy. “In clinical trials, Zoryve cream 0.05% rapidly improved eczema severity, with about 40% of children achieving a 75% improvement and over one-third reporting meaningful itch reduction after just four weeks,” the company says.

Zoryve cream is described as a steroid-free, once-daily formulation designed for long-term, continuous use without compromising the skin barrier. In clinical trials, the treatment was well tolerated, with no new safety concerns identified, the company says.

Atopic dermatitis (eczema) affects about 1.8 million children aged in the U.S. who require topical treatment, Arcutis says. The chronic condition causes intense itching, inflammation, and skin irritation, often disrupting sleep and quality of life for both children and families.