Arcutis Submits sNDA for Roflumilast Cream in the Treatment of Atopic Dermatitis in Patients 6 and Older

Arcutis Biotherapeutics has announced¹ its submission of roflumilast cream 0.15% for a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration for the treatment of atopic dermatitis (AD) in patients ages 6 years and older.

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The announcement comes less than one week after Arcutis shared positive long-term results of roflumilast cream in its phase 3 INTEGUMENT-OLE (NCT04804605) long-term open-label study of roflumilast cream 0.15% in adults and children ages 6 years and older.

In this study, investigators found that 46.1% of pediatric patients and 51.0% of adult patients who had rolled over from the roflumilast treatment arm of the earlier studies, INTEGUMENT-1 or -2, achieved improvement success with a minimum 2-grade improvement from baseline via the validated Investigator Global Assessment-Atopic Dermatitis scale.²

Additionally, 61.5% of pediatric patients and 66.2% of adult patients had achieved a 75% improvement in Eczema Area and Severity Index score from baseline to 28 and 56 weeks. Roflumilast cream was well-tolerated with a low-incidence of treatment-emergent adverse events.²

Read the Dermatology Times® article detailing these long-term results here.

The sNDA submission is also supported by phase 2 dose-ranging study data, according to the press release1 from Arcutis.¹

“Atopic dermatitis is a complex disease. Optimal management of the condition requires a complex balance of treatment, efficacy, safety, tolerability, as well as adherence. Atopic dermatitis patients have sensitive skin and increased risk for developing contact dermatitis from their topical medications,” said Jonathan Silverberg, MD, PhD, MPH, FAAD, in the press release from Arcutis.¹ Silverberg is a professor, director of clinical research, and director of patch testing at George Washington University School of Medicine and Health Sciences.

“Topical roflumilast cream was intentionally formulated with the atopic dermatitis patient in mind, and does not contain excipients that disrupt skin-barrier integrity or are common contact allergens," Silverberg said. "Overall, once-daily topical roflumilast cream has demonstrated in clinical trials a balance of efficacy and tolerability, along with a long-term safety profile, that could support increased adherence for patients with atopic dermatitis."

References

1. Arcutis submits roflumilast cream 0.15% Supplemental New Drug Application to the FDA for the treatment of atopic dermatitis in adults and children ages 6 years and older. Arcutis Biotherapeutics. News release. September 12, 2023. Accessed September 12, 2023. https://www.arcutis.com/arcutis-submits-roflumilast-cream-0-15-supplemental-new-drug-application-to-the-fda-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-ages-6-years-and-older/
2. Arcutis announces positive long-term results of roflumilast cream 0.15% showing durable and improved efficacy over time and favorable safety profile in treatment of mild to moderate atopic dermatitis. Arcutis Biotherapeutics. News release. September 7, 2023. Accessed September 12, 2023. https://investors.arcutis.com/news-releases/news-release-details/arcutis-announces-positive-long-term-results-roflumilast-cream