2016年美国FDA上市新药回顾及重点治疗领域在研药物评述

摘要

The general situation of novel drugs approved by the center for drug evaluation and research of FDA in 2016 was firstly introduced concerning the total numbers and the technological innovation.According to the key therapeutic categories such as oncology,autoimmune diseases and infectious diseases,as well as rare diseases,some of the fist-in-class drugs and the innovative new drugs meeting the demand of patients in the late-stage development were elaborated in this paper,from the perspectives of mechanism,clinical investigation and potential market performance.%文章首先从数量以及技术创新的角度,概述了2016年FDA批准上市新药的总体情况.从药物研发市场的重点治疗领域(肿瘤、自身免疫系统疾病和感染性疾病等)及其罕见病领域,对2016年上市的部分首创新药以及满足患者需求的创新型治疗药物,着重从作用机制、临床研究以及商业前景等角度进行介绍和评述.