Arcutis Biotherapeutics, Inc. announced the U.S. Food and Drug Administration (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. AD is the most common form of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.

Itching (pruritus) is the most burdensome symptom and is the result of skin barrier dysfunction and neuroimmune dysregulation. In clinical trials, ZORYVE cream 0.15% showed rapid, significant, and sustained reduction in itch as soon as 24 hours following the first application. ZORYVE is a next-generation topical phosphodiesterase 4 (PDE4) inhibitor.

PDE4 inhibitors can have a direct effect on the itch-signaling nerves of the skin, as well as the inflammatory pathways. Arcutis intends to make ZORYVE cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July. The Company is dedicated to ensuring predictable access for the ZORYVE portfolio of products, with one simple copay and fulfillment process.

The ZORYVE Direct Program helps patients access their prescribed Arcutis medication. Specifically, this patient support program helps those who have been prescribed ZORYVE to navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients. Arcutis will also continue to offer the Arcutis CaresTM patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.