Arcutis Biotherapeutics, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved ZORYVE® (roflumilast) Cream 0.15% for the treatment of mild-to-moderate atopic dermatitis (AD) in adult and pediatric patients 6 years of age and older.
ZORYVE, a once-daily, steroid-free cream, is a PDE4 inhibitor approved to treat AD, seborrheic dermatitis, and plaque psoriasis.
This supplemental New Drug Application (sNDA) and approval of ZORYVE is based on positive results from the INTEGUMENT-1 and INTEGUMENT-2 phase 3 trials. Both studies were shown to achieve their primary endpoint of Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score which indicated the efficacy of the medication in reducing symptoms. The two double-blind, vehicle-controlled trials included 1,337 adults and children six years and older with mild-to-moderate AD. ZORYVE cream 0.15% or vehicle was applied once daily for four weeks and was found to rapidly and significantly reduce itch, the most bothersome symptom of AD.
Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at UC San Diego School of Medicine and INTEGUMENT study investigator, has stated “The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares. ZORYVE rapidly improves and controls disease, including itch, the most bothersome reported symptom. In clinical trials, 9 in 10 patients saw some improvement at 4 weeks, with 69% of patients demonstrating a clinically meaningful improvement of at least an EASI-50. In addition, ZORYVE is a safe and effective steroid-free treatment option. Topical steroids have been the foundation of treatment for AD for the past 50 years. Having a new and effective steroid-free option, without some of the risks associated with topical and systemic steroids, is a welcome advancement for dermatologists, patients, and caregivers.”
Previous indications include ZORYVE cream, 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older, and ZORYVE foam, 0.3%, for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.
Frank Watanabe, president and chief executive officer of Arcutis, notes “Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream 0.15% as a new steroid-free treatment option to children and adults living with AD. With ZORYVE, our goal has been to provide a steroid-free topical that can provide effective and fast results, wherever on the body it’s needed, and long-term disease control through a safe and tolerable formulation.
Sources:
- FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age. News release. Arcutis Biotherapeutics. July 9, 2024. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-015-treatment
- https://www.ajmc.com/view/fda-approves-roflumilast-for-patients-6-years-and-older-with-atopic-dermatitis