Arcutis Biotherapeutics Secures FDA Approval for ZORYVE Cream to Treat Atopic Dermatitis

1. FDA Approval: The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics' ZORYVE (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adults and children aged 6 years and older.
2. Steroid-Free Treatment: ZORYVE is a once-daily, steroid-free cream designed for long-term disease control, providing rapid disease clearance and significant reduction in itch.
3. Clinical Trials: The approval is supported by positive results from three Phase 3 studies, a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies.
4. Availability: Arcutis plans to make ZORYVE cream 0.15% widely available via key wholesaler and dermatology pharmacy channels by the end of July.
5. Patient Support: The company offers the ZORYVE Direct Program to help patients access their prescribed medication, including a savings card program and a patient assistance program for financially eligible patients.