FDA Approves Roflumilast Cream 0.15% for Treatment of Atopic Dermatitis in Adults and Children Aged 6 and Older

The US Food and Drug Administration (FDA) has approved roflumilast (ZORYVE) cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 and older. Roflumilast is a once-daily, steroid-free cream that provides rapid relief, significant reduction in itch, and long-term disease control.

This approval follows data from the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 trials, which evaluated the safety and efficacy of roflumilast cream in 1,337 adults and children aged 6 and older. Both trials met their primary endpoint, with 32.0% and 28.9% of participants achieving a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of clear or almost clear at week 4 compared to 15.2% and 12.0% in the vehicle group. Approximately 40% of participants treated with roflumilast cream achieved a vIGA-AD score of clear (0) or almost clear (1) at week 4, with significant improvement as early as week 1.

In addition, rapid and significant improvement in itch was observed within 24 hours of the first application. Over 30% of participants achieved at least a 4-point reduction in the Worst Itch-Numeric Rating Scale (WI-NRS) score. More than 40% of participants achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75) at week 4, with significant improvements observed as early as week 1.

The INTEGUMENT-OLE long-term open-label study further demonstrated the safety and efficacy of roflumilast cream over 56 weeks. Participants who achieved a vIGA-AD score of clear (0) with once-daily application switched to twice-weekly application. The median duration of disease control for these participants was 281 days. Overall, 66.2% of participants achieved EASI-75 at week 56.

Roflumilast cream was well tolerated, with most adverse events being mild to moderate in severity. The most common adverse events included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Arcutis Biotherapeutics, Inc., plans to make roflumilast cream 0.15% available by the end of July 2024.

Reference

FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age. News release. Arcutis Biotherapeutics. July 8, 2024. Accessed July 8, 2024. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-015-treatment