摘要
对近5年来特应性皮炎代表性新药的国内外批准情况进行介绍,总结了度普利尤单抗注射液、乌帕替尼缓释片、迪高替尼乳膏、克立硼罗软膏等4种不同作用机制、不同给药途径的特应性皮炎治疗药物的申报资料中临床药理学研究主要内容,以及国内外监管机构对特应性皮炎治疗药物的审评考量,旨在为特应性皮炎新药的早期临床研发和评价提供参考依据。
In this review,the domestic and foreign approvals of representative new drugs for atopic dermatitis in recent five years are introduced,and the main contents of clinical pharmacology studies are summarized,which are in the application materials of four kinds of atopic dermatitis therapeutic drugs with different mechanisms of action and different routes of administration,such as dupilumab,upadacitinib,delgocitinib,crisaborole.Meanwhile,the consideration of domestic and foreign regulatory agencies for these drugs is summarized.The purpose of this review is to provide reference for the early clinical development and evaluation of new drugs for atopic dermatitis.
作者
李娜
衡明莉
王骏
LI Na;HENG Mingli;WANG Jun(Center of Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2022年第9期1894-1902,共9页
Drug Evaluation Research
