FDA顾问委员会支持批准Gilead公司的SOFOSBUVIR为慢性丙型肝炎感

StephenW

FDA  ADVISORY  COMMITTEE  SUPPORTS  APPROVAL  OF  GILEAD’S  SOFOSBUVIR  FOR  CHRONIC  HEPATITIS  C  INFECTION

– Final FDA Decision on Sofosbuvir Anticipated by December 8, 2013 –

Foster City, CA, October 25, 2013 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted unanimously (15-0) that the available data support approval of the once-daily nucleotide analogue sofosbuvir in combination with ribavirin for the treatment of chronic hepatitis C in adult patients with genotype 2 and 3 infection.  Committee members also voted unanimously (15-0) that the available data support approval of sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C in treatment-naïve adult patients with genotype 1 and 4 infection.

The recommendations of the Advisory Committee are not binding, but will be considered by FDA as the agency completes its review of Gilead’s New Drug Application (NDA) for sofosbuvir.  Gilead submitted the NDA on April 8, 2013 and was granted a priority review.  The FDA also granted sofosbuvir a Breakthrough Therapy designation.  The FDA grants Breakthrough Therapy designation and priority review status to drug candidates that may offer major advances in treatment over existing options.  A target review date of December 8, 2013 has been set under the Prescription Drug User Fee Act (PDUFA).  Applications for marketing approval of sofosbuvir are also pending in the European Union, Australia, Canada, New Zealand, Switzerland and Turkey.

The sofosbuvir NDA is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment optionsor historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).  During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA.  In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks.   Patients who achieve SVR12 are considered cured of HCV.

About Sofosbuvir
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication.  Sofosbuvir is a direct-acting agent, meaning that it interferes directly with the HCV life cycle by suppressing viral replication.  Sofosbuvir is an investigational product and its safety and efficacy have not been established.

StephenW

FDA顾问委员会支持批准Gilead公司的SOFOSBUVIR为慢性丙型肝炎感染

- FDA最终决定Sofosbuvir预计2013年12月8日 -

加利福尼亚州福斯特城， 2013年10月25 - 吉利德科学公司（纳斯达克股票代码： GILD ）今天宣布，美国食品和药物管理局（FDA）的抗病毒药物咨询委员会一致投票决定（15-0）可用的数据支持批准每日一次的核苷类似物sofosbuvir与利巴韦林联合治疗慢性丙型肝炎基因型2和3感染成年患者。委员会成员还一致投票决定（15-0）提供的数据支持批准sofosbuvir结合聚乙二醇干扰素和利巴韦林治疗慢性丙型肝炎在治疗初治基因1型和4型感染成人患者。

咨询委员会的建议不具约束力，但会被FDA认为机构完成审查Gilead公司的新药申请（ NDA ） sofosbuvir的。吉利德2013年4月8日提交的NDA被授予优先审查。 FDA还授予sofosbuvir突破性疗法称号。 FDA授予的突破性疗法指定和优先审查资格的候选药物治疗在现有的选项可能提供重大进展。回顾2013年12月8日的目标已经设定下的处方药用户收费法（ PDUFA ） 。营销批准sofosbuvir的应用也有待欧盟，澳大利亚，加拿大，新西兰，瑞士和土耳其。

的sofosbuvir NDA主要由四阶段的3项研究的数据支持，中微子，裂变，正电子和融合，在12周或16周的基于sofosbuvir的治疗被认为是优于或不劣于目前可用的治疗optionsor历史对照，根据谁了（完成（ SVR12 ），治疗HCV检测不到） 12周后持续病毒学应答的患者比例。在审查期间，数据从一个额外的第3阶段研究，价，提交NDA 。在这项研究中，基因3型HCV感染患者与sofosbuvir和利巴韦林治疗24周。丙型肝炎病毒被认为是治愈患者达到SVR12 。

关于Sofosbuvir
Sofosbuvir是一种核苷类似物抑制剂的丙型肝炎病毒聚合酶的酶，它起着至关重要的作用，在HCV复制。 sofosbuvir剂是直动式的，这意味着它直接干扰，通过抑制病毒复制的丙型肝炎病毒的生命周期。 Sofosbuvir是研究产品，其安全性和有效性尚未确立