Business
FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration of useZORYVE foam provides rapid disease clearance and significant reduction in itch, one of the most burdensome symptoms of seborrheic dermatitisFirst drug approved for seborrheic dermatitis with a new mechanism of action in over two decadesSeborrheic dermatitis affects more than 10 million people in the United StatesCommercial product expected to be available by end of JanuaryManagement will host conference call on Monday, December 18 at 8:30 a.m. EST WESTLAKE VILLAGE, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, 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 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. 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. “We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. We are proud to deliver meaningful innovation through this approval of ZORYVE foam, and to offer a new topical treatment that effectively clears and controls the disease and can simplify its management for the millions of adults and adolescents living with seborrheic dermatitis.” Seborrheic dermatitis affects more th...