Ledipasvir/Sofosbuvir Tablet - 11 February 2016 - Medical Chinese

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Main » 2016 » February » 11 » Ledipasvir/Sofosbuvir Tablet
18:45
Ledipasvir/Sofosbuvir Tablet
Ledipasvir/Sofosbuvir Tablet

药品名称:Ledipasvir/Sofosbuvir Tablet

剂型规格:片剂 Ledipasvir(LDV) 90mg 、Sofosbuvir(SOF)400mg

适应症:用于基因型1慢性丙型肝炎成人感染者的治疗

注册类别:化3+6类

产品信息:

据估计,世界范围内大约有1. 7 亿人感染丙型肝炎病毒( HCV) ,占世界总人口的3%。这些感染了HCV 的患者中, 80%会发展成慢性丙肝。慢性丙肝患者中,又有20% 的患者会发展成肝硬化,有25%的可能发展成肝癌。

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。
2013年7月25日,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)。该复方制剂预计2014年底获FDA批准上市。

Ledipasvir介绍:

代号:GS-5885

化学结构式:



化学名称(英文):MethylN-[(2S)-1-[(6S)-6-[5-[9,9-Difluoro-7-[2-[(1S,2S,4R)-3-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]-3-azabicyclo[2.2.1]heptan-2-yl]-3H-benzimidazol-5-yl]fluoren-2-yl]-1H-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-yl]carbamate

化学式:C49H54F2N8O6

分子量:889

CAS.NO:1256388-51-8

研发进展:待申报

合作方式:联合开发、委托开发
Views: 170 | Added by: Weifeng | Tags: Lesovir-C,Twinvir, dhaka,达卡,孟加拉, 治疗 | Rating: 0.0/0
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