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吉利德向FDA提交HIV复方新药F/TAF新药申请  

2016-02-02 11:50:37|  分类: 药物化学 |  标签: |举报 |字号 订阅

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http://news.bioon.com/article/6667907.html

来源:生物谷 2015-04-08 14:53

吉利德向FDA提交HIV复方新药F/TAF新药申请 - zliming2004 - zliming2004的博客

2015年4月7日讯 /生物谷BIOON/ --吉利德(Gilead)近日宣布,已向FDA提交了2种剂量实验性固定剂量组合F/TAF(恩曲他滨/替诺福韦,200/10mg,200/25mg)的新药申请(NDA),寻求批准F/TAF联合其他HIV抗逆转录病毒药物,用于12岁及以上儿童及成人HIV-1感染者的治疗。F/TAF具有高疗效及改善的安全性,该药将为新一代HIV治疗方案提供一个改善的背景配方,将进一步优化HIV患者的临床治疗。吉利德已计划在2015年第二季度向欧盟提交F/TAF的监管申请。

F/TAF的推荐剂量为200/25mg;若与药效增强剂配合使用的蛋白酶抑制剂联合用药,则推荐剂量为200/10mg。

替诺福韦艾拉酚胺富马酸(tenofovir alafenamide fumarate,TAF)是一种新型核苷类逆转录酶抑制剂(NRTI),在临床试验中,该药已被证明在低于吉利德已上市药物Viread(替诺福韦酯,TDF)十分之一剂量时,就具有非常高的抗病毒效果,同时可改善肾功能和骨骼方面参数。Viread也是一种新型NRTI药物,目前被广泛用于HIV(艾滋)和HBV(乙肝)的治疗,该药在2014年的销售额达到了11亿美元。而TAF有望取代Viread,成为吉利德巩固其感染性疾病治疗领域领导者地位的利器。(相关阅读:吉利德HIV治疗新药TAF将有望取代Viread成为新一代利器

此次F/TAF NDA的提交,是吉利德根据F/TAF复方提交的第二个新药申请。2014年11月,吉利德已向FDA提交了四合一HIV新药(E/C/F/TAF,elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg)的新药申请,FDA已指定该药目标日期为2015年11月5日。此外,吉利德于去年12月也向欧盟提交了四合一HIV新药(E/C/F/TAF)的上市许可申请(MAA)。(相关阅读:全球HIV患者新福音:吉利德四合一HIV新药临床大获成功

F/TAF NDA的提交,是基于III期临床项目的数据。该项目评估了基于F/TAF的治疗方案(E/C/F/TAF)在HIV-1感染初治成人患者中的疗效和安全性。数据显示,与基于F/TDF的四合一方案(E/C/F/TDF或Stribild)相比,基于F/TAF的四合一方案(E/C/F/TAF)实现了非劣效性疗效终点,同时改善了肾功能及骨骼方面的参数。同时,F/TAF NDA的提交,也得到了数个额外III期临床试验数据的支持,这些实验评估了基于F/TAF的方案(E/C/F/TAF)在初治青少年群体、切换方案的病毒学抑制成人群体、轻度至中度肾功能损伤成人群体中的疗效和安全性。此外,生物等效性研究表明,F/TAF固定剂量组合实现了与E/C/F/TAF相同的F和TAF血药水平。

目前,吉利德正在开发基于F/TAF的其他复方药物。去年12月,吉利德与强生扩大合作协议,开发2种新的基于F/TAF的复方单片,其中一个药物由F/TAF和rilpivirine组成,另一个药物由F/TAF和cobicistat及darunavir组成。(生物谷Bioon.com)

英文原文:Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment

–Potential New Backbone for Future HIV Therapy Combinations–

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2015-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.

TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread? (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.

“Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “With its high antiviral efficacy and favorable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens.”

Today’s filing is Gilead’s second F/TAF-based NDA submitted to the FDA for review. In November 2014, Gilead filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF). Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 5, 2015. Additionally, a Marketing Authorization Application in the European Union for E/C/F/TAF was fully validated on December 23, 2014.

The F/TAF NDA is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-na?ve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild?). The NDA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among treatment-na?ve adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.

The recommended dose of F/TAF is 200/25 mg; if it is used in combination with a protease inhibitor that is administered with either ritonavir or cobicistat, the recommended dose is 200/10 mg.

Additional F/TAF-based regimens for HIV treatment are currently in development. In December 2014, Gilead announced the expansion of its existing agreements with Janssen Sciences Ireland UC for the development and commercialization of two new investigational once-daily single tablet regimens containing F/TAF. One combines F/TAF with Janssen’s rilpivirine. The other regimen contains F/TAF, cobicistat and Janssen’s darunavir.

Gilead plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.

F/TAF-based regimens are investigational products and have not been determined to be safe or efficacious.

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