美国食品和药物管理局批准了ZORYVE奶油的sNDA,用于治疗25岁儿童的斑块性牛皮;决定时间为2026年6月29日. FDA accepted sNDA for ZORYVE cream to treat plaque psoriasis in children ages 2–5; decision due June 29, 2026.

美国食品和药物管理局已批准Arcutis Biotherapeutics sNDA扩展ZORYVE (roflumilast) 乳液0.3%用于治疗2至5岁儿童的斑块性牛皮,预计将于2026年6月29日作出决定. The FDA has accepted Arcutis Biotherapeutics’ sNDA to expand ZORYVE (roflumilast) cream 0.3% for treating plaque psoriasis in children aged 2 to 5, with a decision expected by June 29, 2026. 这一应用得到了临床数据的支持,这些数据表明,曾经一度热门的PDE4抑制剂对幼儿来说是安全、良好且有效的。 The application is backed by clinical data showing the once-daily topical PDE4 inhibitor is safe, well-tolerated, and effective in young children. 如果获得批准,这将是这一年龄组第一个也是唯一的PDE4热点抑制剂,为影响近900万美国人的一个状况提供无类固醇选择。 If approved, it would be the first and only topical PDE4 inhibitor for this age group, offering a steroid-free option for a condition affecting nearly 9 million Americans.