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美国食品药品监督管理局批准Arcutis Biotheraputics治疗头皮皮肤病的主要药物

FDA Approves Arcutis Biotherapeutics' Lead Drug For Scaly Skin Disorder

benzinga 等信源发布 2023-12-18 07:03

可切换为仅中文


Loading...Loading...The FDA approved Arcutis Biotherapeutics Inc's ARQT Zoryve (roflumilast) topical foam, 0.3% for seborrheic dermatitis in individuals nine years 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.Seborrheic dermatitis affects more than 10 million people in the U.S.

正在加载。。。正在加载。。。FDA批准Arcutis Biotherapeutics Inc的ARQT Zoryve(罗氟司特)局部泡沫,对9岁及以上的脂溢性皮炎患者使用0.3%。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。脂溢性皮炎影响美国1000多万人。

and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales and persistent itch.In the STRATUM trial, Zoryve foam provided rapid disease clearance as early as Week 2 and significant itch relief in as little as 48 hours.

它是一种常见的、慢性的、反复发作的炎症性皮肤病,会导致红色斑块覆盖着大的、油腻的、剥落的黄灰色鳞片和持续的瘙痒。在STREAT试验中,Zoryve泡沫早在第2周就可以快速清除疾病,并在48小时内显着缓解瘙痒。

In addition, almost 80% of patients achieved treatment success at Week 8. Arcutis intends to make Zoryve foam widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of January 2024. In September, Arcutis Biotherapeutics released data from the INTEGUMENT-PED Phase 3 trial of roflumilast cream 0.05% in children ages 2 to 5 years with mild to moderate atopic dermatitis. .

此外,近80%的患者在第8周取得了治疗成功。Arcutis计划在2024年1月底之前,通过主要批发商和皮肤科药房渠道广泛提供Zoryve泡沫,作为一种新的治疗选择。9月,Arcutis Biotherapeutics发布了2至5岁轻度至中度特应性皮炎儿童使用0.05%罗氟司特乳膏的PEGIMENT-PED 3期试验数据。。

For the primary endpoint, 25.4% of children treated once daily with roflumilast cream achieved Investigator Global Assessment Success compared to 10.7% of children treated with the vehicle at Week 4, with significant improvements seen as early as Week 1.Zoryve cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients six years and older.Price Action: ARQT shares are up 22.54% at $2.99 during the premarket session on the last check Monday.Loading...Loading....

对于主要终点,每天用罗氟司特乳膏治疗一次的儿童中有25.4%取得了研究者的全球评估成功,而在第4周用该载体治疗的儿童中有10.7%取得了成功,早在第1周就有显着改善。Zoryve乳膏适用于局部治疗6岁及以上患者的斑块状牛皮癣,包括三叉间区域。价格走势:ARQT股价在周一最后一次检查的上市前交易中上涨22.54%,至2.99美元。正在加载。。。正在加载。。。。