Arcutis Biotherapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at Week 8 in the STRATUM trial. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

Seborrheic dermatitis affects more than 10 million people in the United States, and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. In individuals with darker skin tones, inflamed areas may not appear red, but instead can appear pink, slightly purple, or lighter in color than the surrounding skin. It occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

Hair-bearing areas make applying topicals like creams, gels, and ointments difficult. Beyond the appearance and irritation of physical symptoms, seborrheic dermatitis is associated with a decrease in quality of life and may negatively affect emotional well-being, self-esteem, and day-to-day life, including sleep and work. People with seborrheic dermatitis, and especially adolescents and school-age children, may suffer from social stigma, negative self-image, and low self-esteem associated with very visible skin diseases like seborrheic dermatitis.

Arcutis intends to make ZORYVE foam widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of January 2024. The Company is dedicated to responsible pricing and affordable access to therapy. The ZORYVE® Direct Program helps patients access their prescribed Arcutis medication.

For patients with seborrheic dermatitis who have been prescribed ZORYVE, this patient support program helps patients 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.