The expected PDUFA date is December 16, 2023.
The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics’ New Drug Application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic dermatitis in patients aged 9 years or older. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 16, 2023.1
Arcutis submitted its NDA earlier this year to the FDA and has been eagerly awaiting review acceptance to bring a much-needed treatment option to patients with moderate-to-severe seborrheic dermatitis affecting the scalp, face, and trunk. Roflumilast foam is a once-daily topical foam phosphodiesterase type 4 inhibitor.
Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago, Illinois, and founder of the Chicago Integrative Eczema Center, recently told Dermatology Times® that "As a medical dermatologist, I constantly face common conditions that need fresh solutions. Seborrheic dermatitis is something I see many times per week, and there has been very little innovation in its treatment in my 18 years of practice. Roflumilast has already proven itself to be an excellent addition to our armamentarium for psoriasis, and I am optimistic that it will be valuable in treating seborrheic dermatitis as well. I applaud Arcutis for focusing not only on the drug, but also on the topical formulation, something extremely important in treating skin disorders.”
Arcutis’ NDA submission was based on positive data from the pivotal phase 3 trial, STRATUM (NCT04973228). The phase 3 randomized, parallel-group, double-blind, vehicle-controlled trial examined the safety and efficacy of roflumilast foam 0.3% in patients ≥ 9 years old with at least moderate seborrheic dermatitis affecting the scalp and/or non-scalp areas. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (IGA of clear or almost clear plus a ≥ 2-grade improvement from baseline) at week 8. A total of 457 participants with seborrheic dermatitis were randomized to either roflumilast foam 0.3% (n = 304) or vehicle (n = 153) for 8 weeks. After 8 weeks, 79.5% of patients treated with roflumilast foam 0.3% achieved IGA Success compared to 58.0% of patients treated with vehicle, with early disease improvement observed at week 2.
The incidence of treatment emergent adverse events (TEAEs) was low, with most TEAEs considered mild-to-moderate severity. There were no reported treatment-related serious adverse events. Some of the most common adverse events during the STRATUM trial occurring in ≥1% of patients in the combined phase 2 and phase 3 study populations included nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Frank Watanabe, president and CEO of Arcutis, noted that if roflumilast foam is approved by the FDA, it would be the first topical frug with a new mechanism of action for seborrheic dermatitis in over 2 decades.