FDA Greenlights Arcutis’ Zoryve Cream for Mild-to-Moderate Atopic Dermatitis

The US Food and Drug Administration (FDA) has granted approval for Arcutis Biotherapeutics' Zoryve (roflumilast) cream to be used once daily for the treatment of mild-to-moderate atopic dermatitis (AD) in adults and children aged six years and older. AD is a prevalent inflammatory condition that causes the skin to become itchy, dry, and cracked, affecting roughly 16.5 million adults and 9.6 million children in the United States.

Zoryve is a non-steroidal topical PDE4 inhibitor that had previously received FDA approval for treating seborrhoeic dermatitis and plaque psoriasis. The FDA's recent decision was influenced by data from various clinical trials, including the late-stage INTEGUMENT-1 and INTEGUMENT-2 trials. Over 1,300 AD patients participated in these studies, where they were either administered Zoryve cream 0.15% or a placebo once daily for four weeks.

The trials demonstrated that around 40% of both adult and pediatric patients treated with Zoryve achieved a vIGA-AD score indicating clear or almost clear skin by week four. Significant improvements were also observed as early as the first week of treatment. In addition, the cream provided rapid and notable relief from itching, identified by Arcutis as the most troublesome symptom of AD. Within 24 hours of the initial application, patients reported significant itch relief, and over 40% of those treated with Zoryve experienced a 75% reduction in the Eczema Area and Severity Index by the end of the four-week period, compared to those who received the placebo.

Other studies, including another phase 3 trial, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic studies, also contributed to the FDA's approval decision. Lawrence Eichenfield, an investigator in the INTEGUMENT study from the UC San Diego School of Medicine, highlighted the chronic and unstable nature of AD, which often leaves patients and caregivers feeling overwhelmed. He welcomed the new steroid-free treatment option, noting that it presents a significant advancement for dermatologists, patients, and caregivers, particularly due to its effectiveness and fewer risks compared to topical and systemic steroids.

Arcutis is also exploring the use of Zoryve at a lower dose of 0.05% for treating AD in children aged two to five years. Additionally, the company has completed the clinical development program for Zoryve foam 0.3%, intended for treating scalp and body psoriasis. Arcutis plans to submit a supplemental new drug application for this foam formulation in the third quarter of 2024.