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吉利德提交丙肝新药Ledipasvir/Sofosbuvir新药申请

来源:生物谷 2014-02-13 01:41

2014年2月12日讯 /生物谷BIOON/ --吉利德(Gilead)2月10日宣布,已向FDA提交了ledipasvir(LDV)+sofosbuvir(SOF)固定剂量组合片剂(LDV/SOF,90mg/400mg)新药申请(NDA),该药开发用于基因型1慢性丙型肝炎成人感染者的治疗。据估计,在美国约75%的丙肝患者为基因型1 HCV毒株感染。
此前,FDA已授予LDV/SOF固定剂量组合药物突破性疗法认定。LDV/SOF NDA的提交,是基于3项III期研究(ION-1、ION-2、ION-3)的数据。

吉利德研发执行副总裁兼首席科学官Norbert Bischofberger博士称:“LDV/SOF NDA的提交,使我们离为所有丙型肝炎患者提供一种简单、安全、高效全口服治疗方案的目标更近了一步。根据III期研究的数据,LDV/SOF组合疗法有望在短至8周的时间里治愈基因型1 HCV患者,同时无需注射干扰素或联合利巴韦林(ribavirin)。”

吉利德计划于2014年第一季度,向包括欧盟在内的其他地区监管机构提交LDV/SOF的监管文件。

关于Sovaldi(sofosbuvir):

Sovaldi(400mg片剂)为每日一次的口服核苷类似物聚合酶抑制剂,分别于2013年12月和2014年1月获FDA和欧盟批准,作为抗病毒治疗方案的一部分,用于慢性丙型肝炎(HCV)的治疗。

Sovaldi是首个获批可用于C型肝炎全口服治疗方案的药物,在用于特定基因型慢性丙型肝炎治疗时,可消除对传统注射药物干扰素(IFN)的需求。

具体而言,FDA已批准sofosbuvir联合利巴韦林(ribavirin)用于基因型2和基因型3慢性丙型肝炎(hepatitis C)成人患者的治疗。同时,FDA还批准sofosbuvir联合聚乙二醇干扰素(PEG-IFN)和利巴韦林,用于基因型1和基因型4慢性丙型肝炎初治(treat-naive)成人患者的治疗。(生物谷Bioon.com)

英文原文:Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

-- If Approved, Fixed-Dose Combination Would be First Oral Treatment Regimen for Patients with Genotype 1 HCV Infection, Eliminating Need for Both Interferon and Ribavirin --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (HCV) infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75 percent of people infected with HCV in the United States have the genotype 1 strain of the virus.

“Today’s filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin.”

The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-na?ve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis.

Gilead plans to file for regulatory approval of LDV/SOF in other geographies, including the European Union, in the first quarter of 2014. Gilead has submitted an application to the European Medicines Agency (EMA) for accelerated assessment of LDV/SOF, a designation that is granted to new therapies and medicines of major public health interest. If accepted, accelerated assessment could shorten the EMA’s review time of LDV/SOF by two months, although it does not guarantee a positive opinion from the Committee for Medicinal Products for Human Use or approval by the European Commission.

LDV/SOF is an investigational product and its safety and efficacy has not yet been established.

SOF as a single agent was approved by the FDA under the tradename Sovaldi? on December 6, 2013 and by the European Commission on January 17, 2014.

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