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# Arcutis Biotherapeutics’ Zoryve OK’d for Atopic Dermatitis
- URL: https://www.fdaweb.com/arcutis-biotherapeutics-zoryve-okd-for-atopic-dermatitis/
- Published: 2024-07-10T12:00:00.000Z
- Updated: 2026-09-14T14:35:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157325

FDA has approved an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream, 0.15%, for treating mild to moderate atopic dermatitis in adult and pediatric patients six years of age and older. The once-daily, steroid-free cream is designed to provide rapid disease clearance and significant reduction in itch, the company says.

The submission was based on data from three Phase 3 studies — INTEGUMENT-1 and INTEGUMENT-2 — that met their primary endpoint of investigator global assessment success, which is defined as a score of “*clear* or *almost clear”* plus a two-grade improvement from baseline at Week 4, according to the company. Additionally, the studies showed that rapid and significant improvement in itch was observed in individuals treated with Zoryve cream within 24 hours of the first application, it says.

Regarding safety, Zoryve cream was well tolerated, and most treatment-emergent adverse events were assessed as mild to moderate in severity, Arcutis says. The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Previously, Zoryve cream was approved for topical treatment of plaque psoriasis and for treating seborrheic dermatitis. Atopic dermatitis is described as the most common form of eczema, affecting about 9.6 million children and 16.5 million adults in the U.S.