2016年第一季度美国FDA批准新药简介

2016年第一季度，美国食品药品监督管理局（FDA）共批准新药上市申请（NDA）23件和生物制品许可申请（BLA）3件。其中1类新分子实体（NME）药物仅有3种，分别为治疗癫痫新药布瓦西坦、继 secukinumab 之后上市的第2个 IL-17A单抗抗炎药 ixekizumab，以及 FDA 批准的第1个治疗严重肝小静脉闭塞的药物去纤苷钠。主要对批准的1类 NME 新药进行综述，包括其上市简介、适应症、剂量用法、临床研究等。

A brief introduction of drugs approved by FDA in the first quarter of 2016

Totally 23 drugs of NDA (New Drug Application) and three biological products of BLA (Biological License Applications) were approved by FDA in the first quarter of 2016, including three drugs of NME (new molecular entity). The three NMEs are brivaracetam treating epilepsy, ixekizumab, the second IL-17A anti-inflammatory agent of monoclonal antibody since secukinumab, and defibrotide sodium, the first drug approved by FDA for treating adult and pediatric patients with hepatic veno occlusive disease. This paper reviews all the NMEs, including their marketing introductions, indications, dosage and usage, and clinical researches, etc.