Arcutis Submits sNDA for Roflumilast Foam to FDA for Scalp and Body Psoriasis

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Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for roflumilast foam 0.3% (Zoryve). This application seeks approval for the treatment of both scalp and body psoriasis in adults and adolescents aged 12 and over. This announcement marks a significant milestone for the company and offers hope to the millions of individuals affected by these conditions.Traditional creams and ointments are often difficult to apply effectively in areas with hair, necessitating alternative treatment options.¹

Melinda Gooderham, MD, MSc, FRCPC, medical director of the SKiN Centre for Dermatology and a clinical trial investigator, highlights the unique treatment challenges posed by scalp psoriasis. "Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking," she said in a press release. The investigational roflumilast foam, she noted, effectively clears both scalp and body psoriasis, as demonstrated in clinical trials.

The submission to the FDA is supported by positive results from the pivotal ARRECTOR phase 3 trial (NCT05028582) and a phase 2b study, alongside long-term efficacy and safety data from the roflumilast development program. The ARRECTOR study, a double-blind, vehicle-controlled pivotal phase 3 trial, evaluated the safety and efficacy of roflumilast foam 0.3% in individuals with scalp and body psoriasis aged 12 and older. The study involved 432 participants and met its co-primary endpoints with impressive results.²

According to the trial data, 67.3% of individuals treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) success at week 8, compared to 28.1% of individuals treated with the vehicle foam. Additionally, 46.5% of those treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success, compared to 20.8% of those treated with the vehicle. These findings underscore the efficacy of roflumilast foam in treating both scalp and body psoriasis.

The studies also demonstrated a significant reduction in itch, a common and troublesome symptom of psoriasis. Two-thirds of roflumilast-treated patients with clinically meaningful itch at baseline experienced a clinically significant reduction in itch at week 8, compared to 30.3% of vehicle-treated patients. Notably, some patients reported rapid relief from scalp itch as early as 24 hours after the first application.

The safety profile of roflumilast foam was favorable, with a low incidence of treatment-emergent adverse events (TEAEs) that were generally mild to moderate in severity. The most common adverse reactions included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). Discontinuation rates due to adverse events were low and similar between the roflumilast and vehicle-treated groups.

Frank Watanabe, president and CEO of Arcutis, emphasized the significance of this submission, stating in a press release, "This important milestone represents our fifth topical roflumilast regulatory submission in the United States in less than 3 years and brings another innovative treatment to the large population of individuals with scalp and body psoriasis." He expressed confidence in the potential adoption of roflumilast foam in treating these conditions, given its simplicity and effectiveness in both scalp and body areas.

The potential approval of roflumilast foam could provide a new, steroid-free treatment option for individuals with scalp and body psoriasis, offering relief from the symptoms and improving their quality of life. The FDA will review the sNDA over the next 6 to 10 months before approval.³

References

1. Arcutis submits supplemental new drug application for ZORYVE® (roflumilast) foam to the FDA for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over. News release. Arcutis Biotherapeutics, Inc. July 23, 2024. Accessed July 23, 2024.
2. Bader K. Arcutis presents positive roflumilast foam data from ARRECTOR trial in scalp and body PSO at EADV. Dermatology Times. October 13, 2023. Accessed July 23, 2024. https://www.dermatologytimes.com/view/arcutis-presents-positive-roflumilast-foam-data-from-arrector-trial-in-scalp-and-body-pso-at-eadv
3. Step 4: FDA drug review. US Food and Drug Administration. January 4, 2018. Accessed July 23, 2024. https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-review#:~:text=Directions%20for%20use-,FDA%20Review,whether%20to%20approve%20the%20drug.