FDA Accepts Supplemental NDA for Arcutis’ Roflumilast in Dermatitis

 

• Roflumilast cream 0.05% shows significant efficacy and safety in treating atopic dermatitis in children aged 2 to 5, based on phase 3 trial data.
• The INTEGUMENT-PED trial demonstrated rapid symptom improvement, with 25.4% achieving "clear" or "almost clear" vIGA-AD scores by Week 4.

https://www.dermatologytimes.com/view/fda-accepts-supplemental-new-drug-application-for-arcutis-roflumilast-in-children-with-ad