FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis

发布时间： 2023-12-18 阅读：41次

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December 15, 2023 -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), today announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

“While multiple factors contribute to seborrheic dermatitis, inflammation and skin barrier dysfunction play key roles. ZORYVE has been shown to effectively reduce the signs of inflammation, redness, and scaling in patients with seborrheic dermatitis, and with its unique formulation, ZORYVE foam effectively delivers the drug without disrupting the skin barrier and has been shown to be safe and tolerable. ” said Andrew Blauvelt, MD, MBA, clinical investigator at Oregon Medical Research Center, and investigator on the STRATUM trial.

ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at Week 8 in the STRATUM trial.