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

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。


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。

1  2017FDA批准新药一览表

No.Drug 
Name
Active IngredientApproval DateFDA-approved use on approval dateNews 
21.Kevzarasarilumab5/22/2017To treat adult rheumatoid arthritisLink
20.Radicavaedaravone5/5/2017To treat patients with amyotrophic lateral sclerosis (ALS)
Press Release
Link
19.Imfinzidurvalumab5/1/2017To treat patients with locally advanced or metastatic urothelial carcinoma
Web Post
Drug Trials Snapshot
Link
18.Tymlosabaloparatide4/28/2017To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapiesLink
17.Rydaptmidostaurin4/28/2017To treat acute myeloid leukemia
Press Release
Drug Trials Snapshot
Link
16.Alunbrigbrigatinib4/28/2017To 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.Brineuracerliponase alfa4/27/2017To treat a specific form of Batten disease
Press Release
Link
14.Ingrezzavalbenazine4/11/2017To treat adults with tardive dyskinesia 
Press Release  
Drug Trials Snapshot
Link
13.Austedodeutetrabenazine 4/3/2017 For the treatment of chorea associated with Huntington’s disease 
Drug Trials Snapshot
Link
12.Ocrevusocrelizumab3/28/2017To treat patients with relapsing and primary progressive forms of multiple sclerosis
Press Release
Drug Trials Snapshot
Link
11.Dupixentdupilumab3/28/2017To treat adults with moderate-to-severe eczema (atopic dermatitis)
Press Release
Drug Trials Snapshot
Link
10.Zejulaniraparib3/27/2017For 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.Bavencioavelumab3/23/2017To treat metastatic Merkel cell carcinoma
Press Release
Drug Trials Snapshot
Link
7.Xadagosafinamide3/21/2017To treat Parkinson’s disease
Press Release
Drug Trials Snapshot
Link
6.Kisqaliribociclib3/13/2017To treat postmenopausal women with a type of advanced breast cancer
Drug Trials Snapshot
Link
5.Xermelotelotristat ethyl2/28/2017To treat carcinoid syndrome diarrhea
Press Release
Drug Trials Snapshot
Link
4.Siliqbrodalumab2/15/2017To treat adults with moderate-to-severe plaque psoriasis
Press Release
Drug Trials Snapshot
Link
3.Emflazadeflazacort2/9/2017To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD)
Press Release
Drug Trials Snapshot
Link
2.Parsabivetelcalcetide2/8/2017To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis
Drug Trials Snapshot
Link
1.Trulanceplecanatide1/19/2017To 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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