Posted by Michael Wonder on 14 Sep 2023
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
12 September 2023 - In pivotal Phase 3 trials, roflumilast cream demonstrated statistically significant improvements over vehicle on the primary endpoint of Investigator Global Assessment success at Week 4, as well as on key secondary outcomes including rapid improvement in itch.
Arcutis Biotherapeutics today announced the submission of a supplemental new drug application to the US FDA for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 years and older.
