THURSDAY, July 11, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Zoryve (roflumilast) cream, 0.15 percent, for the treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients (ages 6 years and older).
Zoryve is a once-daily, steroid-free cream that the company says will be available at the end of July.
The approval was based on results from the INTEGUMENT-1 and 2 phase 3 trials, in which 1,337 participants with mild-to-moderate atopic dermatitis were assigned to Zoryve cream, 0.15 percent, or vehicle applied once daily for four weeks. Across studies, approximately 40 percent of participants treated with Zoryve cream achieved a validated Investigator Global Assessment-Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5 versus 25.2 percent; INTEGUMENT-2: 39.0 versus 16.9 percent), with significant improvement seen as early as week 1. More than 40 percent of participants treated with Zoryve cream achieved a 75 percent reduction in the Eczema Area and Severity Index at week 4 versus vehicle (INTEGUMENT-1: 43.2 versus 22.0 percent; INTEGUMENT-2: 42.0 versus 19.7 percent).
“People suffering from atopic dermatitis experience intense itch, rash, and sensitive skin, which warrant effective, safe, and well-tolerated treatments,” Jonathan Silverberg, M.D., Ph.D., from the George Washington University School of Medicine in Washington, D.C., said in a statement. “Zoryve was developed with the atopic dermatitis patient in mind, to deliver the drug in a moisturizing vehicle that is formulated without common sensitizers or irritants and does not further disrupt the abnormal skin barrier.”
Approval of Zoryve was granted to Arcutis Biotherapeutics.
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