FDA Approves Arcutis Biotherapeutics’ Zoryve to Treat Patients with Mild to Moderate Atopic Dermatitis

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The FDA has approved Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.15% for mild to moderate atopic dermatitis (AD) in adults and children over six years of age. According to the company, the treatment is steroid-free and moves quickly to clear the disease, resulting in significant itch reduction. The approval was based on results from three Phase III studies, a Phase II dose-ranging study, and two Phase I pharmacokinetic studies.¹

“The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics, vice chair, department of dermatology, UC San Diego School of Medicine, INTEGUMENT study investigator, in a press release. “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.”

INTEGUMENT-1 and INTEGUMENT-2 are two identical Phase III, parallel group, double-blind, vehicle-controlled trials evaluating the safety and efficacy of Zoryve cream 0.15% or vehicle applied once daily for four weeks to 1,337 adults and children over the age of six years with mild to moderate AD. The primary endpoint of both trials was a validated Investigator Global Assessment—Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear plus a 2-grade improvement from baseline at four weeks.

Overall, results found that over 40% of children and adults treated with Zoryve experienced a 75% reduction in Eczema Area and Severity Index (EASI-75) at week four compared to vehicle (INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, P<0.0001). Additionally, 30% of the group treated with Zoryve in both studies achieved success at week four based on the daily Worst Itch-Numeric Rating Scale (WI-NRS) score, with reduction being reported at the end of the first week of the study.

Results also found that the cream was well tolerated, with treatment-emergent adverse events (TEAEs) occurring in low numbers for both arms of the studies. A majority of TEAEs were reported as mild to moderate in severity. The most common TEAEs included headache, nausea, application site pain, diarrhea, and vomiting.

The INTEGUMENT-OLE open-label study was a rollover study that included 658 participants from INTEGUMENT-1 or -2. At any point after four weeks, patients who achieved a vIGA-AD score of clear after applying the treatment once-daily switched to twice-weekly application.¹

“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,” said Frank Watanabe, president, CEO, Arcutis, in the press release. “Zoryve is the fastest-growing steroid-free topical, relied on to provide effective and safe results in any location on the skin for any duration. With the addition of the new 0.15% strength of Zoryve cream for AD to the higher-strength cream and foam products, the Zoryve portfolio has the potential to become the preferred topical brand in dermatology.”

Reference

1. FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age. GlobeNewswire. July 9, 2024. Accessed July 10, 2024. https://www.globenewswire.com/en/news-release/2024/07/09/2910781/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-15-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-Down-to-6-Years-of-Age.html#