FDA Approves Zoryve for Atopic Dermatitis
By Lori Solomon HealthDay Reporter
THURSDAY, July 11, 2024 -- 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted July 2024
Read this next
AAP Updates Guidelines for Pediatric Atopic Dermatitis Management
MONDAY, May 19, 2025 -- In a clinical report published online May 19 in Pediatrics, the American Academy of Pediatrics presents updated guidance for the treatment of children...
Global Burden of Atopic Dermatitis in Older Adults Is Considerable
WEDNESDAY, May 7, 2025 -- The global burden of atopic dermatitis (AD) in older adults is considerable and is expected to continue increasing to 2050, according to a study...
Early-Onset Pediatric Atopic Dermatitis Tied to Higher Risk for Uveitis
WEDNESDAY, April 23, 2025 -- Children with early-onset atopic dermatitis (AD) have an elevated risk for pediatric uveitis, according to a study published online April 3 in...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.