Gilead разработал альтернативу собственному Стрибилду (Quad)
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07.11.2014
Компания Gilead Sciences Inc. направила в Управление по контролю за пищевыми продуктами и лекарственными средствами США (FDA) заявку на регистрацию перорального комбинированного препарата для лечения ВИЧ-инфекции у взрослых пациентов. Лекарственное средство содержит элвитегравир (150 мг), кобицистат (150 мг), эмтрицитабин (200 мг) и тенофовир алафенамид (10 мг), являющийся ключевым элементом новой комбинации. Исследования показали, что, несмотря на аналогичность его действия тенофовиру, сопоставимая противовирусная активность тенофовира алафенамида наблюдается при введении пациентам в 10 раз меньших доз.
Ранее одобрение и разрешение на продажу в США и Евросоюзе получил комбинированный антиретровирусный препарат "Стрибилд" (Quad). B состав единой таблетки входят 4 лекарственных вещества - все разработаны компанией "Gilead Sciences": элвитегравир 150 мг, эмтрицитабин 200 мг, кобицистат (бустер, аналогичный ритонавиру) 150 мг и тенофовира дизопроксил 245 мг.
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(Источник: http://www.dddmag.com/news/2014/11/gilead-submits-application-new-hiv-pill-fda )
Gilead Submits Application for New HIV Pill to FDA
Gilead Sciences Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults. The data submitted in the NDA support the use of the regimen among adult and adolescent treatment-naïve HIV individuals, virologically suppressed patients who switch regimens and those with renal impairment. If approved, E/C/F/TAF would be Gilead’s first single tablet regimen to contain TAF.
TAF is an investigational, novel prodrug of tenofovir, the active agent in Gilead’s Viread (tenofovir disoproxil fumarate). TAF is a more targeted form of tenofovir than Viread that has demonstrated high antiviral efficacy at a dose that is 10 times lower, as well as an improved renal and bone safety profile.
“This TAF-based regimen has the potential to provide a range of HIV patients with a highly effective and well-tolerated new treatment option with a favorable safety profile,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Gilead remains focused on advancing next-generation therapies that have the potential to improve HIV treatment over the long-term and TAF will be the cornerstone of future Gilead single tablet regimens.”
The NDA for E/C/F/TAF is supported by 48-week data from two pivotal Phase 3 studies in which the regimen met its primary objective of non-inferiority compared to Gilead’s Stribild among treatment-naïve patients. In the studies, E/C/F/TAF demonstrated improved renal and bone safety compared to Stribild. The NDA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among virologically suppressed patients who switched to E/C/F/TAF and among patients with renal impairment. In addition, the filing is supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components and the co-formulated single tablet regimen.
Gilead plans to submit a regulatory application for E/C/F/TAF in the European Union by the end of 2014.
TAF and TAF-based regimens are investigational products and have not been determined safe or efficacious.
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Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV – High Rates of Viral Suppression and Improved Renal and Bone Safety Demonstrated in Phase 3 Studies – – First of Several TAF-Based Single Tablet Regimens Being Evaluated by Gilead - (See more at: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1986740#sthash.SGHazNh9.dpuf )
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 6, 2014-- 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 an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults. The data submitted in the NDA support the use of the regimen among adult and adolescent treatment-naïve HIV individuals, virologically suppressed patients who switch regimens and those with renal impairment. If approved, E/C/F/TAF would be Gilead’s first single tablet regimen to contain TAF.
TAF is an investigational, novel prodrug of tenofovir, the active agent in Gilead’s Viread® (tenofovir disoproxil fumarate). TAF is a more targeted form of tenofovir than Viread that has demonstrated high antiviral efficacy at a dose that is 10 times lower, as well as an improved renal and bone safety profile.
“This TAF-based regimen has the potential to provide a range of HIV patients with a highly effective and well-tolerated new treatment option with a favorable safety profile,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Gilead remains focused on advancing next-generation therapies that have the potential to improve HIV treatment over the long-term and TAF will be the cornerstone of future Gilead single tablet regimens.”
The NDA for E/C/F/TAF is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the regimen met its primary objective of non-inferiority compared to Gilead’s Stribild®(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve patients. In the studies, E/C/F/TAF demonstrated improved renal and bone safety compared to Stribild. The NDA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among virologically suppressed patients who switched to E/C/F/TAF and among patients with renal impairment. In addition, the filing is supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components and the co-formulated single tablet regimen.
Gilead plans to submit a regulatory application for E/C/F/TAF in the European Union by the end of 2014.
TAF and TAF-based regimens are investigational products and have not been determined safe or efficacious.
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