FDA approves Zoryve for atopic dermatitis

The U.S. Food and Drug Administration has approved Arcutis Biotherapeutics’ Zoryve (roflumilast) cream, 0.15%, 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 two Phase III trials, in which 1,337 participants with mild-to-moderate atopic dermatitis were assigned to Zoryve cream, 0.15%, or vehicle applied once daily for four weeks.

Across studies, approximately 40% of participants treated with Zoryve cream achieved a validated Investigator Global Assessment-Atopic Dermatitis score of clear (0) or almost clear (1) at week four (INTEGUMENT-1: 41.5 versus 25.2%; INTEGUMENT-2: 39.0 versus 16.9%), with significant improvement seen as early as week one.

More than 40% of participants treated with Zoryve cream achieved a 75% reduction in the Eczema Area and Severity Index at week four versus vehicle (INTEGUMENT-1: 43.2 versus 22.0%; INTEGUMENT-2: 42.0 versus 19.7%).

“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.”

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