鲁索替尼乳膏！
Ruxolitinib Receives MMA Validation from EMA for VitiligoNovember 5, 2021
Linda Stocum, Assistant Editor
Conference |American College of Allergy, Asthma and Immunology
Incyte announced that ruxolitinib cream has received validation for its European marketing authorization application from the European Medicines Agency.
Ruxolitinib (Opzelura; Incyte) cream, a topical Janise Kinase (JAK) inhibitor, has received European Marketing Authorization Application (MAA) validation from the European Medicines Agency (EMA) for the potential treatment for patients 12 years and older with non-segmental vitiligo with facial involvement.1
“The EMA’s validation of the MAA for ruxolitinib cream marks an important milestone for people with vitiligo, for whom there is often a significant impact on everyday life and who currently have limited treatment options,” said Jonathan Dickinson, general manager Europe, executive vice president at Incyte, Switzerland. “We are committed to listening to the patient community to understand how we can help fulfill unmet needs and support healthcare providers to better manage this challenging disease. We look forward to working with the regulatory authorities, with the aim to bring this new potential therapy to eligible patients as soon as possible.”
The results from the 2 phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), supported the decision.
The clinical trial program evaluated the safety and efficacy of ruxolitinib cream in more than 600 patients aged 12 and older with vitiligo. Results from the trials demonstrated significant improvements in facial and total body repigmentation at 24 weeks of treatment with ruxolitinib cream in patients with vitiligo. In the studies, patients using ruxolitinib cream did not report clinically significant application site reactions, and the overall safety profile was consistent with previous study data, according to the release.
Data like this and more will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) annual sc
这个MMA认证是什么呢？没有百度到
是上市许可吗？
https://www.bbsls.net//mobcent//app/data/phiz/default/06.pnghttps://www.bbsls.net//mobcent//app/data/phiz/default/06.png欧洲可真快 这FD A什么时候也通过 希望国内也快整上
这是特效药吗很贵吗 欧洲真快
这是世界获批的首款药膏用于治疗白白的吧
加油
什么时候来中国
期待国内尽快上市！
谢谢分享，期待国内尽快上市！ 应该是效果很好，期待期待，看来要有有效的药膏还要寄希望于国外医生啊
我又了解了下，这个新闻稿是转载的10月28日的INCYTE官方通告，里面并没有提及已经通过欧洲上市申请，只是说申请表被接收了。具体的通过时间最多长达7个月，也就是说最晚明年5月底会有最终审批结果。
关键国内啥时能买到，真的是
蜜昕 发表于 2021-11-6 11:45 static/image/common/back.gif
这是特效药吗很贵吗
目前对大多数人来说是最有效药。现在很贵，大概两、三万60g。
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