FDA approves Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis – Arcutis Biotherapeutics

Arcutis Biotherapeutics, Inc. announced the 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.

“We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Zoryve foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. We are proud to deliver meaningful innovation through this approval of Zoryve foam, and to offer a new topical treatment that effectively clears and controls the disease and can simplify its management for the millions of adults and adolescents living with seborrheic dermatitis.”

Seborrheic dermatitis affects more than 10 million people in the United States.

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 Cares patient assistance program (PAP) that provides Zoryve at no cost for financially eligible patients who are uninsured or underinsured.