Story perspectives
FDA Approves Roflumilast Cream for Young Eczema Patients
10/6/2025
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Story summary
- The FDA approved roflumilast cream 0.05% (Zoryve) for children 2 to 5 with mild-to-moderate atopic dermatitis.
- This is the sixth roflumilast approval in just over three years.
- Approval rests on INTEGUMENT-PED and INTEGUMENT-OLE trials, with 39.4% reaching Eczema Area and Severity Index (EASI-75) by week 4.
- Availability in the U.S. is expected by late October 2025, with insurer support.
