新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 葛兰素史克 » 葛兰素史克HIV新药Tivicay获FDA批准

葛兰素史克HIV新药Tivicay获FDA批准

来源:生物谷 2013-08-13 13:13

2013年8月13日讯 /生物谷BIOON/ --葛兰素史克(GSK)8月12日宣布,FDA已批准Tivicay(dolutegravir)50mg片剂。

Tivicay为每日一次的口服药物,是HIV整合酶抑制剂,旨在与其他抗逆转录病毒制剂联合用于既往已治疗过、或初治HIV-1成人和12岁及以上体重至少40千克儿童感染者。

Tivicay新药申请(NDA)的提交,包括4个关键性III期临床试验(SPRING-2、SINGLE、SAILING、VIKING-3)数据。

关于III期临床项目:

SPRING-2:在822例HIV感染者中开展,评价了每天1次Tivicay与每天2次raltegravir(拉替拉韦)与一种固定剂量双NRTI疗法联合治疗的疗效。48周时,含Tivicay方案有88%的患者实现病毒学抑制(HIV-1 RNA<50 c/ml),含raltegravir方案为86%,达到了10%的非劣性标准。

SINGLE:在833例初治HIV感染者中开展,评价了每天1次Tivicay+阿巴卡韦/拉米夫定相对于单一片剂Atripla的疗效。48周时,含Tivicay方案有88%的患者实现病毒学抑制(HIV-1 RNA<50 c/ml),Atripla方案为81%,数据具有统计学显着差异。Tivicay方案组有2%患者因不良事件中止治疗,Atripla方案组为10%。

SAILING:在719例经当前疗法治疗失败但未使用整合酶抑制剂治疗的患者中开展,评价了每天1次Tivicay和每天2次raltegravir(拉替拉韦)结合一种背景方案(2种制剂,其中至少1种完全活性剂)的疗效。24周时,含Tivicay方案有79%的患者实现病毒学抑制(HIV-1 RNA<50 c/ml),含raltegravir方案为70%,数据具有统计学显着差异。

VIKING-3:在183例正在接受治疗、且HIV已对数类HIV药物(包括整合酶抑制剂雷特格韦和/或elvitegravir)的成人感染者中开展。该项研究中,背景方案中添加Tivicay治疗7天后,HIV RNA水平下降达1.4 log10 c/ml。24周时,添加Tivicay方案有63%的患者实现病毒学抑制(HIV-1 RNA<50 c/ml)。

批准Tivicay用于12岁及以上、体重至少40千克儿童的适应症,是基于一项多中心、开发标签试验的安全性、药代动力学、药效评价数据。该项研究在既往未接受过整合酶抑制剂治疗的患者中开展。(生物谷Bioon.com)

英文原文:FDA Approves New GlaxoSmithKline HIV Drug

ViiV Healthcare announces U.S. approval of Tivicay? (dolutegravir) for the treatment of HIV-1

London, UK, 12 August, 2013 ViiV Healthcare is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved Tivicay? (dolutegravir) 50-mg tablets. Tivicay is an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs).  “Today is a very important milestone for patients and the scientists and teams who developed Tivicay and brought it to this point of FDA approval. I am very proud that we are serving people living with HIV with a much-needed new treatment option. Today’s approval shows that our singular focus on HIV can deliver important new medicines, maintaining our absolute commitment to the HIV/AIDS global response,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.The submission included data from four pivotal Phase III clinical trials that treated 2,557 adults (who received at least one dose of study medication) with HIV across the treatment spectrum; it also included data in children aged 12 years and older. Tivicay was used without a pharmacokinetic boosting agent. Tivicay can be taken with or without food and at any time of the day.“In many regimens, the differentiating component is the third agent. Tivicay provides a new opportunity for healthcare professionals to choose the right regimen for their patients, providing a focal point around which to individualise therapy,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “HIV treatment should not be a ‘one-size fits all’ paradigm.” This wide-ranging Phase III programme included two trials in treatment-na?ve patients: one where a once-daily Tivicay-based regimen was compared to twice-daily raltegravir and another where the regimen of once-daily Tivicay and abacavir/lamivudine was compared to once-daily Atripla?[1] (efavirenz/emtricitabine/tenofovir disoproxil fumarate). It also included treatment-experienced patients who had not previously been treated with an integrase inhibitor, where a once-daily, Tivicay-based regimen was compared to twice-daily raltegravir. The fourth trial studied treatment-experienced patients with resistance to multiple classes of HIV medicines, including resistance to integrase inhibitors, where the effectiveness of twice-daily Tivicay on viral load was evaluated. About the Phase III Clinical Trial ProgrammeSPRING-2 was a study evaluating once-daily Tivicay versus twice-daily raltegravir in 822 HIV-infected, treatment-na?ve patients, in each case in combination with a fixed-dose dual-NRTI treatment. At week 48, the proportion of study participants who were virologically suppressed (HIV-1 RNA <50 c/mL) was 88% for the regimen containing Tivicay and 86% for the regimen containing raltegravir, meeting the 10% non-inferiority criteria. The tolerability of Tivicay was similar to that of raltegravir, with adverse events leading to withdrawal at 2% in both arms. There were no treatment-emergent adverse drug reactions of at least moderate intensity (Grades 2 to 4) and ≥2% frequency in the Tivicay or raltegravir arms in SPRING-2. No treatment-emergent genotypic resistance to Tivicay or the background regimen was seen in the Tivicay arm in SPRING-2. SINGLE was a study evaluating once-daily Tivicay plus abacavir/lamivudine versus the single tablet regimen Atripla in 833 HIV-infected, treatment-na?ve patients. At 48 weeks, the proportion of study participants who were virologically suppressed (HIV-1 RNA <50 c/mL) was 88% for the Tivicay regimen and 81% for Atripla. This difference was statistically significant. Overall, 2% of subjects on the Tivicay-based regimen discontinued due to adverse events versus 10% of those receiving the Atripla regimen. For Tivicay, treatment-emergent adverse drug reactions of at least moderate intensity (Grades 2 to 4) and ≥2% frequency in SINGLE were insomnia (3%) and headache (2%). Treatment-emergent adverse drug reactions of at least moderate intensity (Grades 2 to 4) and ≥2% frequency for Atripla were rash (6%), dizziness (5%), nausea (3%), and insomnia, abnormal dreams, headache, diarrhoea, and vertigo (2%).No treatment-emergent genotypic resistance that resulted in reduced susceptibility to either Tivicay or the background regimen was seen in the Tivicay arm in SINGLE.SAILING was a study evaluating once-daily Tivicay versus twice-daily raltegravir in 719 patients with HIV who were failing on current therapy, but had not been treated with an integrase inhibitor, in each case in combination with an investigator-selected background regimen consisting of up to two agents, including at least one fully active agent. At week 24, 79% of patients on the regimen containing Tivicay were virologically suppressed (HIV-1 RNA <50 c/mL) versus 70% of patients on the regimen containing raltegravir. This difference was statistically significant. Overall, the tolerability of Tivicay was similar to that of raltegravir, with adverse events leading to withdrawal at 2% for the Tivicay regimen versus 4% for the raltegravir regimen. There were no treatment-emergent adverse drug reactions of at least moderate intensity (Grades 2 to 4) and ≥2% frequency in the Tivicay arm. The only treatment-emergent adverse drug reaction of at least moderate intensity (Grades 2 to 4) and ≥2% frequency in the raltegravir arm was diarrhoea (2%). Viruses from five of 15 subjects in the Tivicay arm with post-baseline resistance data had evidence of treatment-emergent genetic changes (integrase substitutions). However, none of these patients had decreases in susceptibility to either Tivicay or raltegravir. VIKING-3 was a study evaluating twice-daily Tivicay in 183 HIV-infected adults currently on medication whose HIV was resistant to multiple classes of HIV medicines, including integrase inhibitors (raltegravir and/or elvitegravir). In the study, mean HIV RNA levels declined by 1.4 log10 c/mL after seven days of treatment with the addition of Tivicay to their background regimen. The proportion of study participants who were subsequently virologically suppressed (HIV-1 RNA <50 c/mL) with the addition of Tivicay to their background regimen was 63% at week 24. However, poor virologic response was observed in subjects treated with Tivicay twice daily with an integrase strand transfer inhibitor (INSTI) resistance called Q148 plus two or more additional INSTI resistance substitutions. The rate of adverse events leading to discontinuation was 3% of subjects at week 24. Treatment-emergent adverse drug reactions in VIKING-3 were generally similar compared with observations with the once-daily, 50-mg dose in Phase III trials of adult patients. The indication in children aged 12 years and older and weighing at least 40 kg (88 lbs) is based on an evaluation of safety, pharmacokinetics, and efficacy through 24 weeks in a multi-centre, open-label trial in patients who have not previously been treated with integrase inhibitors.

葛兰素史克行贿风波相关新闻阅读:

英媒:葛兰素史克考虑退出中国 不想承担200亿罚单http://www.bioon.com/industry/enterprisenews/581601.shtml

葛兰素史克回应:“千万公关费”是业务问题http://www.bioon.com/industry/enterprisenews/581460.shtml

葛兰素史克高层默许在中国行贿 年公关费上千万http://www.bioon.com/industry/enterprisenews/581359.shtml

中国针对葛兰素史克等药企反腐对医药市场增长产生很大影响http://www.bioon.com/industry/mdnews/581174.shtml

葛兰素史克风波新进展:年送大客户近千万 高管收受康辉贿赂http://www.bioon.com/industry/mdnews/581118.shtml

2013上半年美国FDA批准的新药名单 13种新药葛兰素史克(GSK)占三种http://www.bioon.com/industry/internation/580721.shtml

葛兰素史克HIV新药Tivicay获FDA批准http://www.bioon.com/industry/drug/579460.shtml

葛兰素史克案发酵:扬子江等国企会议费更惊人http://www.bioon.com/industry/mdnews/579297.shtml

葛兰素史克糖尿病新药被FDA延迟审批http://www.bioon.com/biopharm/578659.shtml

葛兰素史克否认因“行贿门”裁员百人http://www.bioon.com/industry/mdnews/578223.shtml

葛兰素史克将更换中国高管 在华团队大换血http://www.bioon.com/industry/mdnews/577957.shtml

葛兰素史克中国业务至少18人被拘http://www.bioon.com/industry/mdnews/577947.shtml

葛兰素史克涉贿案引发药品降价期待http://www.bioon.com/industry/mdnews/577809.shtml

葛兰素史克中国区运营几乎瘫痪 研发中心涉造假http://www.bioon.com/industry/mdnews/577804.shtml

葛兰素史克研发再曝黑幕 在华违规进行人体试验http://www.bioon.com/industry/enterprisenews/577802.shtml

葛兰素史克:医生最欢迎吃不死治不好高价药http://www.bioon.com/industry/mdnews/577800.shtml

葛兰素史克称对贿赂案感到羞耻 对涉案员工深感失望http://www.bioon.com/industry/enterprisenews/577693.shtml

葛兰素史克:二季度中国销售额20亿人民币 99.9%的员工都是正派的http://www.bioon.com/industry/enterprisenews/577692.shtml

路透社:葛兰素史克CEO本周三将在季报中解释中国行贿案http://www.bioon.com/industry/internation/577231.shtml

公安部约见葛兰素史克高层 后者承诺降药价http://www.bioon.com/industry/mdnews/577209.shtml

葛兰素史克该成为“落水狗”吗?http://www.bioon.com/z/zmb/column/201307/577006.shtml

葛兰素史克高管细数关系单位 药监总局发改委等被点名http://www.bioon.com/industry/mdnews/576938.shtml

英金融时报:葛兰素史克派人赴华展开内部调查http://www.bioon.com/industry/enterprisenews/576927.shtml

英金融时报:葛兰素史克案凸显中国医疗体制扭曲http://www.bioon.com/industry/mdnews/576925.shtml

葛兰素史克英国籍中国财务总监被限制离境http://www.bioon.com/industry/mdnews/576888.shtml

外媒:葛兰素史克贿赂丑闻涉700家公司5亿美元http://www.bioon.com/industry/mdnews/576734.shtml

关于葛兰素史克中国区行贿的十个“为什么”http://www.bioon.com/industry/mdnews/576736.shtml

葛兰素史克就涉贿道歉:支持中国政府根除腐败http://www.bioon.com/industry/mdnews/576696.shtml

葛兰素史克深陷贿赂丑闻 医药行业潜规则浮出水面http://www.bioon.com/industry/mdnews/576622.shtml

跨国药企葛兰素史克在华行贿推高药价内幕披露http://www.bioon.com/industry/enterprisenews/576563.shtml

葛兰素史克贿赂案调查:旅行社成药企黑金池http://www.bioon.com/industry/mdnews/576558.shtml

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库