Arcutis announces submission of sNDA to FDA for roflumilast cream 0.15%

Arcutis Biotherapeutics announced the submission of a supplemental New Drug Application, sNDA, to the U.S. Food and Drug Administration, FDA, for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 years and older. “Topical therapies are foundational therapy for the vast majority of individuals who use pharmaceuticals to treat their atopic dermatitis, but today’s topicals come with limitations. People suffering from atopic dermatitis want fast-acting, steroid-free, topical treatments that are effective and well tolerated,” said Frank Watanabe, President and Chief Executive Officer of Arcutis. “This is particularly important given the prevalence of the disease in children, where safety and tolerability are of particularly great concern when considering which treatment to use. Both healthcare professionals and patients or parents deserve to feel confident in the treatment decisions they make.”