2014年10月15日美国食品和药品监督管理局(FDA)批准Ofev(nintedanib)为特发性肺纤维化(IPF)的治疗。
特发性肺纤维化是一种条件其中随时间肺逐渐地成为瘢痕。其结果，有IPF患者经受气短，咳嗽，和很难参加每天体力活动。对IPF的当前治疗包括氧疗，肺功能康复，和肺移植。
FDA药品评价和研究中心药物评价II室副主任Mary H. Parks, 医学博士说：“对有特发性肺纤维化患者，一种严重 ，慢性肺病，Ofev批准扩展提供一种可得到的新的治疗选择” 。“提供卫生保健专业人员和患者有另外的治疗选择有助于能够根据患者需求决定适当医护。”
FDA授予Ofev快速通道，优先审评，孤儿产品，和突破性治疗指定。Ofev正在超出监管局完成药物申请审评产品处方药物使用者费用被批准目标日期2014年1月2日。
Ofev是一种激酶抑制剂阻断涉及肺组织瘢痕化的多个通路。在1,231例有IPF患者三项临床试验中确定其安全性和有效性。用力肺活量下降 –在可能的最深呼吸后从肺可以强制呼出的空气量–接受 Ofev患者与接受安慰剂患者比较显著减低。
在有中度至严重肝问题患者建议不用Ofev。Ofev可能至出生缺陷或 胎儿死亡。当服用Ofev 时妇女不应成为妊娠。能够妊娠妇女和在Ofev末次剂量后至少三个月应使用适当避孕。
The most common side effects of Ofev的最常见副作用是腹泻，恶心，腹痛，呕吐，肝酶升高，食欲减退，头痛，体重减轻，和高血压。
FDA在今天还批准 Esbriet (pirfenidone)为治疗突发性肺纤维化[IPF]。.
Ofev由康涅狄格州里奇菲尔德的勃林格殷格翰制药公司分发。
包装规格：
100mg*60软胶囊/盒 150mg*60软胶囊
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm
New Drugs Online Report for nintedanib
Information
Generic Name: nintedanib
Trade Name: Ofev
Synonym: BIBF 1120, intedanib
Entry Type: Licence extension
Developmental Status
UK: Pre-registration (Filed)
EU: Pre-registration (Filed)
US: Pre-registration (Filed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
July 14: FDA has granted Breakthrough Therapy designation to nintedanib for the treatment of people with idiopathic pulmonary fibrosis (IPF). The efficacy and safety of nintedanib in the treatment of IPF has not been established. [15]
17/07/2014 09:28:10
Jul 14: FDA accepts filing & grants nintedanib priority review [14].
04/07/2014 11:09:47
Jun 14: EMA agrees to an accelerated review [13].
09/06/2014 16:10:04
May 14: EU marketing authorisation application for nintedanib submitted. This included results from two Phase III trials with identical design, INPULSIS™-1 and INPULSIS™-2. [12]
06/06/2014 16:05:34
Mar 14: EU filing will be via the centralised procedure [9].
21/03/2014 11:25:08
May 13: Orphan designation (EU/3/13/1123) granted in the EU for the treatment of idiopathic pulmonary fibrosis [6].
15/05/2013 11:22:10
Apr 11: PIII studies start [3].
20/04/2011 09:47:34
PII [1]
02/03/2011 13:37:38