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FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older
First and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis, including intertriginous psoriasis Approved for once-daily treatment in
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"First and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis, including intertriginous psoriasis Approved for once-daily treatment in mild, moderate, and severe plaque psoriasis with no limitations on duration of useEstablished efficacy – provides rapid clearance of plaques and reduction of itch in all affected areas of the body Safe and very well-tolerated, steroid-free cream with minimal application site reactionsCommercial product expected to be available by mid-August Management will host conference call on Monday, August 1 at 8:30 a.m. EDTArcutis expects to draw an additional $125 million from the Company’s debt facility with SLR Capital Partners WESTLAKE VILLAGE, Calif., July 29, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, ZORYVE provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body. ZORYVE — a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation — is uniquely formulated to simplify disease management for people living with plaque psoriasis. “Today Arcutis has reached a major milestone, with our ability to offer this next generation topical PDE4 inhibitor to both adults and adolescents with plaque psoriasis. ZORYVE's combination of efficacy, safety, and tolerability, coupled with our proprietary HydroARQ Technology formulation, is designed to fit into patients’ everyday lives with no restrictions on duration of use,” said Frank Watanabe, President and CEO of Arcutis. “Additionally, ZORYVE has been shown to rapidly clear plaques and reduce itch across all areas of the body. ZORYVE is the only topical for which data focused on the treatment of intertriginous plaques — a common area affected by plaque psoriasis — have been specifically generated. This FDA approval is the fruition of our efforts, and we are excited to lau...