FDA approves Zoryve (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age – Arcutis Biotherapeutics

Arcutis Biotherapeutics, Inc. announced the FDA has approved the supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Zoryve is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control.

“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 and vice chair of the department of dermatology at UC San Diego School of Medicine and INTEGUMENT study investigator. “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.”

People suffering from AD experience intense itch, rash, and sensitive skin, which warrant effective, safe, and well-tolerated treatments,” said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology, and the director of clinical research and director of contact dermatitis at The George Washington University School of Medicine and Health Sciences in Washington, D.C. “Zoryve was developed with the AD 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. It’s also important to note that in clinical trials Zoryve monotherapy provided safe and effective long-term disease control to AD patients.”.