Loading...Loading...On Tuesday, the FDA approved Arcutis Biotherapeutics Inc’s ARQT supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for mild to moderate atopic dermatitis in patients six years of age and older.“Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream 0.15% as a new steroid-free treatment option to children and adults living with AD,” said Frank Watanabe, president and CEO of Arcutis.Arcutis intends to make Zoryve cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July.In the first quarter of 2024, the Zoryve franchise generated sales of $21.6 million, with $15 million for Zoryve cream, 0.3%, and $6.5 million for Zoryve topical foam, 0.3%; sales growth was 675% year over year and 59% sequentially.Results from three Phase 3 studies, a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies support the sNDA.INTEGUMENT-1 and INTEGUMENT-2 phase 3 trials met their primary endpoint of IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear plus a 2-grade improvement from baseline..

正在加载。。。正在加载。。。周二，FDA批准Arcutis Biotherapeutics Inc的ARQT补充新药申请（sNDA）用于Zoryve（罗氟司特）乳膏，0.15%，用于治疗6岁及以上患者的轻度至中度特应性皮炎。Arcutis总裁兼首席执行官弗兰克·渡边（FrankWatanabe）表示：“今天是FDA在过去两年内第三次批准用于Arcutis的商业产品，我们很高兴能够为患有AD的儿童和成人提供0.15%的ZORYVE乳膏作为一种新的无类固醇治疗选择。”。Arcutis计划在7月底之前，通过主要批发商和皮肤科药房渠道，将0.15%的Zoryve乳膏作为一种新的治疗选择广泛提供。2024年第一季度，Zoryve特许经营产生了2160万美元的销售额，其中Zoryve霜1500万美元，0.3%，Zoryve局部泡沫650万美元，0.3%；销售额同比增长675%，同比增长59%。三项3期研究，一项2期剂量范围研究和两项1期药代动力学研究的结果支持sNDA。INTEGUMENT-1和INTEGUMENT-2 3期试验达到了IGA成功的主要终点，定义为经过验证的研究者全球评估-特应性皮炎（vIGA AD）评分清晰或几乎清晰，加上比基线改善2级。。

Individuals treated with Zoryve cream experienced rapid and significant improvement in itch within 24 hours of the first application.

用Zoryve乳膏治疗的患者在第一次使用后24小时内瘙痒迅速显着改善。

In addition, over 40% of children and adults treated with Zoryve cream achieved a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 compared to vehicle.

此外，与媒介物相比，使用Zoryve乳膏治疗的40%以上的儿童和成人在第4周时湿疹面积和严重程度指数（EASI-75）降低了75%。

In both studies, significant improvements based on EASI-75 were observed with ZORYVE cream compared to the vehicle as early as Week 1.

在这两项研究中，早在第1周，ZORYVE乳膏就观察到基于EASI-75的显着改善。

Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.Roflumilast cream for atopic dermatitis is currently being evaluated at a lower dose of 0.05% for children aged 2 to 5 years.In addition, Arcutis has completed its clinical development program for Zoryve foam 0.3% for scalp and body psoriasis and intends to submit an sNDA in the third quarter of 2024.Price Action: ARQT shares were down 5.29% to $9.49 at the last check on Wednesday.Read Next:.

特应性皮炎是最常见的湿疹类型，在美国约有960万儿童和1650万成年人受到影响。目前，对于2至5岁的儿童，罗氟司特乳膏治疗特应性皮炎的剂量较低，为0.05%。此外，Arcutis已完成其针对头皮和身体牛皮癣的0.3%Zoryve泡沫的临床开发计划，并计划在2024年第三季度提交sNDA。价格行动：周三最后一次检查时，ARQT股价下跌5.29%至9.49美元。。

Why Is Longeveron Stock Soaring On Wednesday?

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