FDA Accepts sNDA for Roflumilast Foam as Scalp, Body Psoriasis Treatment

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has accepted the Supplemental New Drug Application (sNDA) for roflumilast foam 0.3% (ZORYVE®) for the treatment of scalp and body psoriasis in adults and adolescents aged ≥12 years.¹

Announced by Arcutis Biotherapeutics, Inc., on September 24, 2024, the sNDA was supported by positive data from the pivotal ARRECTOR Phase 3 trial, a Phase 2b study, and long-term efficacy and safety data from the roflumilast cream development program. The FDA has set a PDUFA target action date of May 22, 2025.

“In clinical studies, investigational once-daily ZORYVE foam has demonstrated significant improvements in psoriasis signs and symptoms, effectively and reliably improving both scalp and body psoriasis across all efficacy endpoints compared to vehicle,” said Jennifer Soung, MD, director of clinical research at Southern California Dermatology.¹ “...The unique formulation of [roflumilast] foam is potentially a transformative new treatment option, if approved, for those living with scalp and body psoriasis.”

Approximately 9 million individuals in the US with plaque psoriasis experience scalp involvement, with frequent plaques on other body areas.² Scalp-related symptoms are often burdensome for patients, with challenges related to the application of traditional creams or ointments in hair-bearing areas.

Roflumilast foam is a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor, formulated for use anywhere on the body, including hair-bearing areas.³ The sNDA for roflumilast foam was submitted by Arcutis in July, based on significant improvements reported in the Phase 3 pivotal trial.

The parallel-group, double-blind, vehicle-controlled ARRECTOR study assessed the safety and efficacy of roflumilast foam 0.3% or matching vehicle administered daily in participants aged ≥12 with plaque psoriasis of the scalp and body.¹

Among 432 participants in ARRECTOR, more than half (66.4%) treated with roflumilast foam achieved Scalp-Investigator Global Assessment Success at Week 8, compared with 27.8% of patients in the vehicle foam arm (P <.0001). Approximately 45.5% of patients treated with roflumilast foam met Body-Investigator Global Assessment Success criteria, compared with 20.1% of the vehicle arm at Week 8 (P <.0001).

More roflumilast-treated patients (63.5%) with clinically meaningful itch at baseline achieved a clinically significant reduction in Scalp Itch-Numeric Rating Scale (≥4-point change) over the vehicle arm (30.3%) at Week 8 (P <.0001). Arcutis indicated some patients experienced rapid scalp itch relief 24 hours after the first application compared with vehicle (P = .0164).

Improvement in body itch also favored roflumilast foam, with 63.1% achieving a ≥4-point reduction in the Worst Itch-Numeric Rating Scale, compared with 30.1% of the vehicle arm (P <.0001). Safety data showed roflumilast foam met tolerability criteria, with a similar, low incidence of treatment-emergent adverse events (TEAEs) in both the roflumilast foam and vehicle arms.

The most common adverse reactions for roflumilast foam across both the Phase 3 and Phase 2b studies included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). Discontinuation due to adverse events remained low, with similar rates to roflumilast-treated and vehicle-treated patients in pooled vehicle-controlled studies.

“ZORYVE foam, if approved, would represent a truly meaningful innovation for millions of people with scalp and body psoriasis whose symptoms have not been adequately addressed by existing treatments,” said Frank Watanabe, president and chief executive officer of Arcutis.¹ “We look forward to working closely with the FDA during the review process for our fifth topical roflumilast regulatory submission in the United States in less than three years.”

References

1. _{FDA accepts Arcutis’ Supplemental New Drug Application for ZORYVE® (ROFLUMILAST) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over. Arcutis Biotherapeutics. September 24, 2024. Accessed September 24, 2024. https://www.arcutis.com/fda-accepts-arcutis-supplemental-new-drug-application-for-zoryve-roflumilast-foam-for-the-treatment-of-scalp-and-body-psoriasis-in-adults-and-adolescents-ages-12-and-over/.}
2. _{Mosca M, Hong J, Hadeler E, Brownstone N, Bhutani T, Liao W. Scalp Psoriasis: A Literature Review of Effective Therapies and Updated Recommendations for Practical Management. Dermatol Ther (Heidelb). 2021;11(3):769-797. doi:10.1007/s13555-021-00521-z}
3. _{Smith T. Arcutis Submits sNDA for Roflumilast Foam as Treatment for Scalp, Body Psoriasis. HCP Live. July 23, 2024. Accessed September 24, 2024. https://www.hcplive.com/view/arcutis-submits-snda-roflumilast-foam-treatment-scalp-body-psoriasis.}