Roflumilast Cream 0.15% Approved for Treatment of Atopic Dermatitis in Adults, Children: Daily Dose

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On July 11, 2024, we reported on the US Food and Drug Administration (FDA) approval of the supplemental new drug application for roflumilast cream 0.15% (Zoryve) for the treatment of mild-to-moderate atopic dermatitis (AD) in adults and children as young as age 6 years.

The approval

Zoryve is a steroid-free topical applied once a day and has been developed specifically for long-term disease control.

The FDA based its approval on positive results from the 3 phase 3 INTEGUMENT registration trials, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic studies. INTEGUMENT-1 and INTEGUMENT-2 were identical, parallel-group, double-blind, vehicle-controlled, trials that evaluated the safety and efficacy of roflumilast cream 0.15% or vehicle applied once-daily to affected skin for 4 weeks. The studies enrolled 1337 adults and children aged 6 years and older with mild to moderate AD.

Both studies met the shared primary endpoint, a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) and a 2-grade improvement from baseline at week 4 (INTEGUMENT-1: 32.0% roflumilast cream vs 15.2% vehicle) and INTEGUMENT-2: 28.9% roflumilast cream vs 12.0% vehicle) (P <.001 for both). In both studies, 40% of all participants treated with roflumilast cream achieved a vIGA-AD score of 0 or 1 at week 4, with significant improvement seen as early as week 1 (P <.001 for all).

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