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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.
ZORYVE泡沫是一种高效、安全、耐受性良好的每日一次无类固醇泡沫,可用于身体所有受影响的部位,包括毛发生长部位,使用时间不受限制ZORYVE泡沫可快速清除疾病并显着减少瘙痒,脂溢性皮炎最严重的症状之一是第一种被批准用于脂溢性皮炎的药物,其作用机制已超过20年。美国有1000多万人患有脂溢性皮炎。预计1月底将推出该商业产品。管理层将于12月18日星期一上午8:30主持电话会议。
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.
加利福尼亚州EST WESTLAKE VILLAGE,2023年12月15日(环球通讯社)--Arcutis Biotherapeutics,Inc.(纳斯达克:ARQT),一家早期商业化公司,专注于开发免疫皮肤病学方面有意义的创新,今天宣布美国食品和药物管理局(FDA)已批准ZORYVE(罗氟司特)外用泡沫的新药申请(NDA),0.3%用于治疗9岁及以上个体的脂溢性皮炎。
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.
ZORYVE泡沫可快速清除疾病并显着减少瘙痒,近80%的个体达到IGA成功的主要疗效终点,而在STREAT试验中,超过50%的个体在第8周达到完全清除。ZORYVE是一种每日一次的无类固醇泡沫,是二十多年来第一种被批准用于脂溢性皮炎的药物,具有新的作用机制。
“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 lo.
“我们从皮肤科临床医生和脂溢性皮炎患者那里了解到,由于缺乏疗效,难以治疗某些身体部位,治疗方案不方便以及对lo安全性的担忧,疾病清除和治疗依从性一直存在真正的斗争。