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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
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United StatesIn pivotal Phase
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United StatesIn pivotal Phase 3 trials, roflumilast cream demonstrated statistically significant improvements over vehicle on the primary endpoint of Investigator Global Assessment (IGA) Success at Week 4, as well as on key secondary endpoints including rapid improvement in itchRoflumilast cream was well tolerated and demonstrated a favorable safety and tolerability profile during up to 56 weeks of treatment WESTLAKE VILLAGE, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today 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 (AD) in adults and children ages 6 years and older. “Atopic dermatitis is a chronic and relapsing disease that occurs across the lifespan. In clinical studies, once-daily roflumilast cream provided rapid clearance of the disease. In addition, roflumilast cream rapidly reduced itch, one of the most bothersome symptoms to patients, in as little as twenty-four hours,” said Eric Simpson, MD, MCR, FAAD, Professor of Dermatology at Oregon Health & Science University in Portland, Oregon, and investigator in the Phase 3 INTEGUMENT trials. “The INTEGUMENT studies’ novel approach also incorporated assessment of twice weekly proactive treatment in the long-term study, which demonstrated that, once clear, patients could maintain adequate control by staying ahead of the condition rather than chasing flares. Together, these data suggest that roflumilast cream, if approved, could provide a simplified approach to disease control.” Roflumilast cream is a once-daily, steroid-free, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. Roflumilast cream is uniquely formulated with HydroARQ Technology™ as a non-greasy emollient cream that absorbs quickly and does not disrupt the skin barrier. In addition, roflumilast cream does not include sensitizing excipients or irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fra...