FDA批准为2至11岁患有无节制外皮皮炎的儿童提供Opzelura奶油。 FDA approves Opzelura cream for children 2–11 with uncontrolled atopic dermatitis.

食药局已批准为2至11岁儿童提供1.5%的Opzelura奶油(ruuxolitinib), The FDA has approved Opzelura cream 1.5% (ruxolitinib) for children aged 2 to 11 with mild-to-moderate atopic dermatitis not well-controlled by other topical treatments or when they’re not recommended. 这是首个已批准用于该年龄组的局部JAK抑制剂,提供短期非持续使用的非类固醇选择. It’s the first topical JAK inhibitor approved for this age group, offering a nonsteroidal option for short-term, noncontinuous use. 批准的基础是第3阶段TruE-AD3号试验,在治疗成功和风疹改善方面比安慰剂结果好得多。 Approval is based on the phase 3 TRuE-AD3 trial, showing significantly better results than placebo in treatment success and eczema improvement. 上呼吸道感染是最常见的副作用,没有新的安全问题。 Upper respiratory tract infection was the most common side effect, with no new safety concerns. 由Incyte研制的这一药物为影响儿童生活质量的慢性病提供了一种新的治疗选择。 The drug, developed by Incyte, provides a new treatment option for a chronic condition affecting children’s quality of life.