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Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age
Regulatory submission for the expanded indication is supported by data from two recently completed 4-week Maximal Usage Systemic Exposure (MUSE) studies in
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Regulatory submission for the expanded indication is supported by data from two recently completed 4-week Maximal Usage Systemic Exposure (MUSE) studies in children ages 2 to 11 years with plaque psoriasisIf approved, ZORYVE would be the first steroid-free topical phosphodiesterase-4 (PDE4) inhibitor for children with plaque psoriasisZORYVE has been shown to be safe and very well tolerated, with minimal local site reactions WESTLAKE VILLAGE, Calif., Dec. 19, 2022 (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 the expanded indication of ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11. As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features. ZORYVE was approved by the FDA in July 2022 for the topical treatment of plaque psoriasis in adults and adolescents 12 years of age and older. ZORYVE is a steroid-free, topical PDE4 inhibitor which effectively clears plaque psoriasis in both hard-to-treat areas such as knees and elbows, as well as sensitive areas such as the face, intertriginous areas, and genitalia. “Safety and tolerability are critically important in the treatment of children, and today young children lack treatment options for plaque psoriasis. This submission is an exciting step in our efforts to expand the availability of an effective, steroid-free treatment for children with plaque psoriasis,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. “ZORYVE is the first PDE4 approved for the treatment of psoriasis and, if approved by the FDA with the new data, dermatology clinicians will be able to treat patients down to 2 years of age.” “ZORYVE demonstrated a favorable safety and tolerability profile in this pediatric population, with minimal local site reactions. ZORYVE, with our proprietary HydroARQ Technology™, is a non-greasy, moisturizing cream that spreads easily and is aesthetically pleasing to patients, and most importantly does not include sensitizing excipients or irritants such as propylen...