Positive topline results from a pair of identical phase 3 trials support the submission of a supplemental New Drug Application to the FDA for Arcutis Biotherapeutics’ roflumilast cream 0.15%, a once-daily topical to treat mild to moderate atopic dermatitis (AD) in children 6 years or older.
A supplemental New Drug Application (sNDA) has been submitted to the FDA by Arcutis Biotherapeutics for roflumilast cream 0.15%, a steroid-free, once-daily topical to treat mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older, according to a September 2023 press release from the company.1
The sNDA submission follows positive data from 2 phase 3 trials, INTEGUMENT-1 (NCT04773587) and INTEGUMENT-2 (NCT04773600. The studies were identical phase 3, double-blind, parallel-group, and vehicle-controlled clinical trials. Participants, 6 years or older with mild to moderate AD involving 3% or more body surface area, were treated with roflumilast cream 0.15% or vehicle once a day for 4 weeks.1
Each study the primary endpoint of a Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1), plus a 2-grade improvement from baseline at week 4 (INTEGUMENT-1: 32% roflumilast cream vs 15.2% vehicle [P < 0.0001]) and (INTEGUMENT-2: 28.9% roflumilast cream vs 12% vehicle [P < 0.0001]). For more results and explanation of these clinical trials, click here.1
“Atopic dermatitis is a complex disease,” said Jonathan Silverberg, MD, PhD, MPH, FAAD, professor, director of clinical research, director of Patch Testing at George Washington University School of Medicine and Health Sciences, Washington, DC. “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. 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. 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.”1
Arcutis Biotherapeutics announced positive data from the INTEGUMENT-PED (NCT04845620) phase 3 trial of roflumilast 0.05% to treat children aged 2 to 5 years with mild to moderate AD. Following the announcement of these phase 3 trial results, the company intends to submit a sNDA for roflumilast cream 0.05%.2