Company submits supplemental NDA for topical atopic dermatitis treatment.

Latest News Arcutis Biotherapeutics has submitted a supplemental NewDrug Application (sNDA) to the Food and DrugAdministration for roflumilast cream 0.15% for thetreatment of mild to moderate atopic dermatitis (AD) inadults and children aged 6 years and older. Submission of the sNDA is based on positive resultsfrom the Interventional Trial Evaluating Roflumilast Creamfor the Treatment of Atopic Dermatitis (INTEGUMENT-1 andINTEGUMENT-2) trials; two identical Phase 3, vehicle-controlledtrials in which roflumilast cream 0.15% or vehiclewas applied once daily for 4 weeks to individuals 6 years ofage and older with mild to moderate AD involving at least3% body surface area. [Extracted from the article]