Arcutis Biotherapeutics, Inc. has announced the FDA approval of ZORYVE® (roflumilast) cream 0.05% for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years. This approval is supported by findings from the INTEGUMENT-PED Phase 3 trial, the INTEGUMENT-OLE long-term extension study, and a Phase 1 pharmacokinetic study.
The INTEGUMENT-PED trial involved 652 children and demonstrated rapid clearance of atopic dermatitis, with significant improvements as early as Week 1. By Week 4, 25.4% of children treated with ZORYVE achieved a vIGA-AD Success score compared to 10.7% with the vehicle (P<0.0001). Additionally, 39.4% of children on ZORYVE showed a 75% reduction in Eczema Area and Severity Index (EASI-75) by Week 4.
ZORYVE cream was well-tolerated, with common side effects including upper respiratory infections and gastrointestinal issues. In the INTEGUMENT-OLE study, efficacy was maintained or improved over 56 weeks, with 71.9% of children achieving a 75% improvement in EASI.
ZORYVE provides a non-steroidal treatment option for atopic dermatitis, aiming to improve outcomes for young patients. The product is expected to be commercially available by the end of October 2025.
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Elevate-Derm Alliance Editorial Committee