FDA

Zoryve now approved for atopic dermatitis in younger children

October 13, 2025

FDA has approved the supplemental new drug application for Zoryve (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age.

Efficacy

Approval of Zoryve cream 0.05% was based on data from the phase 3 INTEGUMENT-PED trial (NCT04845620), the INTEGUMENT-OLE long-term extension study (NCT04804605), and a Phase 1 pharmacokinetic study. Zoryve demonstrated rapid clearance of atopic dermatitis, with positive results across all efficacy endpoints.

In the INTEGUMENT-PED trial, Zoryve demonstrated rapid disease clearance, with data showing significant improvements as early as week 1. At Week 4, 25.4% of children treated with Zoryve cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘Clear’ or ‘Almost Clear’, plus a 2-grade improvement from baseline, vs. 10.7% of children treated with vehicle (P<0.0001).

The study also met all secondary endpoints, with improvements seen across all time points, including vIGA-AD of ‘Clear’ and ‘Almost Clear’ at week 1. Additionally, 39.4% of children using Zoryve cream achieved a 75% reduction in Eczema Area and Severity Index (EASI-75) at week 4 compared with 20% using vehicle, with differences observed as early as week 1 (exploratory endpoint).

Zoryve was also shown to reduce itch at week 4, with some caregivers reporting less itching within 24 hours after first application. In an exploratory analysis, over one-third of children who had a baseline Worst Itch Numeric Scale (WI-NRS) score ≥4 (as reported by the caregiver) achieved a four-point reduction in WI-NRS at Week 4 (vs. 18% for vehicle-treated children [nominal P=0.0002]).

Safety

The most common adverse reactions reported in the clinical trials were upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache.

Sources:

Zoryve (roflumilast) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215985s012lbl.pdf Revised October 2025. Accessed October 10, 2025.

FDA approves Arcutis’ Zoryve® (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. [News release]. 2025. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-atopic-dermatitis-in-children-ages-2-to-5/