FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Patients 9 Years and Older

Approval seen as step forward in treatment of seborrheic dermatitis.

Arcutis Biotherapeutics, Inc. announced the US 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 those 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, they said in a press release.

"Seborrheic dermatitis is a common yet poorly understood chronic dermatosis associated with redness, flaking, and itch in characteristic areas of the body, including the head and neck," Raj Chovatiya, MD, PhD, explained in an interview with Practical Dermatology. Recent studies have suggested that the burden of this disease is much higher than previously appreciated, with many patients waiting years for appropriate diagnosis and not achieving longitudinal control with conventional, unapproved, non-targeted therapy (namely, topical corticosteroids), resulting in immense polypharmacy, according to Dr. Chovatiya, who is an assistant professor of dermatology at the Northwestern University Feinberg School of Medicine in Chicago, IL.

The debate about primary pathogenic drivers in this condition, along with difficulty in efficiently delivering a drug to hair-bearing areas, have been two important reasons why drug development has been slow in this space, according to Dr. Chovatiya.

"The approval of roflumilast 0.3% foam is a major step forward in treatment of this disease," he said. "As a phosphodiesterase-4 inhibitor in a water-based foam vehicle, we now have a treatment that targets a key enzyme in the inflammatory cascade (suggesting the primary importance of immune dysregulation in this disease) that can easily be delivered to the areas of the skin that need it most."

 In addition, based on the phase 3 clinical trials in which roflumilast was studied, he noted, a majority of patients achieved complete skin clearance in weeks and had meaningful improvement in itch.

"It's exciting to see how this treatment will not only change our primary approach to seborrheic dermatitis, but also promote further investigation into this disease and development of novel therapeutics."