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FDA授予吉利德sofosbuvir NDA优先审查资格

来源:生物谷 2013-06-12 14:41

2013年6月11日讯 /生物谷BIOON/ --吉利德科学(Gilead Sciences)上周末宣布,FDA已授予sofosbuvir新药申请(NDA)优先审查资格。

Sofosbuvir是一种每日一次的口服核苷类似物抑制剂,用于慢性丙型肝炎病毒(HCV)感染的治疗。

吉利德于2013年4月8日提交了sofosbuvir的NDA,FDA已指定的处方药用户收费法(PDUFA)完成sofosbuvir NDA审查的日期为2013年12月8日。

Sofosbuvir NDA所包含的数据,支持了将sofosbuvir与利巴韦林(RBV)作为一种全口服疗法用于基因型2型和3型HCV感染的治疗,以及将sofosbuvir与利巴韦林、聚乙二醇干扰素(PEG-IFN)用于基因型1型、4型、6型HCV感染的治疗。

如果获批,sofosbuvir将成为用于C型肝炎治疗的首个全口服组合治疗方案中的重要组成部分,并有望消除传统注射药物的需求。

据Gilead估计,sofosbuvir一旦上市,市值将达110亿美元。(生物谷bioon.com)

英文原文:Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 7, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options. Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013.

The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-na?ve patients with genotype 1, 4, 5 and 6 HCV infection.

Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.

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