基列的文件为美国批准Ledipasvir / Sofosbuvir固定剂量复方片剂的

StephenW

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-naïve 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 theEuropean 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.

StephenW

基列的文件为美国批准Ledipasvir / Sofosbuvir固定剂量复方片剂的基因型1丙型肝炎

- 如果获得批准，固定剂量组合将是第一个口服治疗方案治疗基因1型丙型肝炎病毒感染，消除极品双方干扰素和利巴韦林 -
福斯特城，加利福尼亚州 - （美国商业资讯） - 二月10 ， 2014  - 吉利德科学公司（Nasdaq ： GILD ）今天宣布，该公司已经提交了一份新药申请（ NDA）给美国食品和药物管理局（ FDA）的的每日一次的固定剂量组合NS5A抑制剂ledipasvir （ LDV） 90毫克和核苷酸类似物聚合酶抑制剂sofosbuvir （SOF） 400毫克用于治疗慢性丙型肝炎基因型1感染治疗成人。提交的NDA的数据支持患者的基因型1丙型肝炎病毒（ HCV）感染的利用LDV / SOF ，用八周或12周根据既往治疗史及是否有肝硬化的治疗时间。约75 ％的人在美国感染HCV的具有基因型1毒株的病毒。
“今天的归档使我们更接近了一步我们提供所有患者的丙型肝炎一种简单，安全，高效的全口腔治疗方案的目标，”诺伯特Bischofberger ，博士，研究与发展兼首席科学官的执行副总裁说。 “根据从第3阶段离子研究的数据，该LDV / SOF组合可以具有治愈HCV基因型1的患者在短短的八个星期而不需要注射干扰素或利巴韦林的可能性。 ”
FDA已经指定的LDV / SOF一个突破性疗法称号，这是给予研究药物可能提供重大进展的治疗比现有的方案。新发展区的LDV / SOF是由三个阶段3研究中， ION - 1 ， ION- 2和ION -3 ，其中近2000基因型1丙型肝炎患者随机接受固定剂量组合，带或不带RBV ，为八， 12或24周的治疗持续时间。试验参与者包括谁是治疗初治或谁没有以前的治疗，包括蛋白酶抑制剂为基础的方案，也包括患者的代偿性肝硬化患者。
吉利德计划在其他地区，包括欧盟立案LDV / SOF的监管部门的批准，在2014年第一季度。吉利德已经为LDV / SOF ，被授予新的治疗方法和主要的公共健康利益的药品的指定加速评估提交申请，要求欧洲药品管理局（EMA ） 。如果接受，加速评估可以缩短LDV / SOF的EMA的审查时间由两个月了，尽管它并不能保证从医药产品委员会为人力使用或核准theEuropean委员会提出积极的意见。
LDV / SOF是一种调查产品及其安全性和有效性尚未确立。
SOF为单剂，商品名为Sovaldi被FDA批准® 12月6日，2013年及由欧盟委员会于2014年1月17日。