2017年FDA批准新药名单，上半年已达21种！

2017-05-25 诸平诸平

据FDA官网（http://www.fda.org）2017年5月22日提供的最新公布结果，截止2017年5月22日，FDA已经批准了21种新药，约占2016年FDA批准新药数量（22种）的95%，去年创造新药新低，今年有望获得重大突破，甚至能创造近年来审批新药的新高。2011-2017年5月5日FDA批准新药数量变化见图1所示。图1 FDA2011-2017年批准新药数量变

据 FDA官网（http://www.fda.org）2017年5月22日提供的最新公布结果，截止2017年5月22日，FDA已经批准了21种新药，约占2016年FDA批准新药数量（22种）的95%，去年创造新药新低，今年有望获得重大突破，甚至能创造近年来审批新药的新高。2011-2017年5月5日FDA批准新药数量图。

图1 FDA2011-2017年批准新药数量变化

2017年以来（截止2017年5月22日）FDA批准新药名单。

表1 2017年FDA批准新药一览表

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date	News
21.	Kevzara	sarilumab	5/22/2017	To treat adult rheumatoid arthritis	Link
20.	Radicava	edaravone	5/5/2017	To treat patients with amyotrophic lateral sclerosis (ALS) Press Release	Link
19.	Imfinzi	durvalumab	5/1/2017	To treat patients with locally advanced or metastatic urothelial carcinoma Web Post Drug Trials Snapshot	Link
18.	Tymlos	abaloparatide	4/28/2017	To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies	Link
17.	Rydapt	midostaurin	4/28/2017	To treat acute myeloid leukemia Press Release Drug Trials Snapshot	Link
16.	Alunbrig	brigatinib	4/28/2017	To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Drug Trials Snapshot	Link
15.	Brineura	cerliponase alfa	4/27/2017	To treat a specific form of Batten disease Press Release	Link
14.	Ingrezza	valbenazine	4/11/2017	To treat adults with tardive dyskinesia Press Release Drug Trials Snapshot	Link
13.	Austedo	deutetrabenazine	4/3/2017	For the treatment of chorea associated with Huntington’s disease Drug Trials Snapshot	Link
12.	Ocrevus	ocrelizumab	3/28/2017	To treat patients with relapsing and primary progressive forms of multiple sclerosis Press Release Drug Trials Snapshot	Link
11.	Dupixent	dupilumab	3/28/2017	To treat adults with moderate-to-severe eczema (atopic dermatitis) Press Release Drug Trials Snapshot	Link
10.	Zejula	niraparib	3/27/2017	For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers Press Release Drug Trials Snapshot	Link
9.	Symproic	naldemedine	3/23/2017	For the treatment of opioid-induced constipation Drug Trials Snapshot	Link
8.	Bavencio	avelumab	3/23/2017	To treat metastatic Merkel cell carcinoma Press Release Drug Trials Snapshot	Link
7.	Xadago	safinamide	3/21/2017	To treat Parkinson’s disease Press Release Drug Trials Snapshot	Link
6.	Kisqali	ribociclib	3/13/2017	To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot	Link
5.	Xermelo	telotristat ethyl	2/28/2017	To treat carcinoid syndrome diarrhea Press Release Drug Trials Snapshot	Link
4.	Siliq	brodalumab	2/15/2017	To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot	Link
3.	Emflaza	deflazacort	2/9/2017	To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD) Press Release Drug Trials Snapshot	Link
2.	Parsabiv	etelcalcetide	2/8/2017	To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis Drug Trials Snapshot	Link
1.	Trulance	plecanatide	1/19/2017	To treat Chronic Idiopathic Constipation (CIC) in adult patients. Press Release Drug Trials Snapshot	Link

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA). For instance, new information may become available which could lead to a reconsideration of the original designation or status. If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

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作者：诸平

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