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欧洲委员会授权Gilead'sVemlidy®用于治疗乙型肝炎病毒感染

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发表于 2017-1-12 08:35 |显示全部帖子

European Commission Grants Marketing Authorization for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection

-- Vemlidy® is the First New Treatment for Chronic Hepatitis B Infection to be Approved in the European Union in Nearly a Decade --
January 11, 2017 06:53 AM Eastern Standard Time

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg).

The marketing authorization allows for the marketing of TAF in the 28 countries of the European Union, Norway and Iceland.

“As the first new treatment for chronic hepatitis B to be approved in Europe in nearly a decade, this approval marks a step forward in the management of a progressive, life-threatening disease affecting 13 million Europeans,” said Professor Pietro Lampertico, Head of the Gastroenterology and Hepatology Division at the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Italy. “Treating a lifelong disease such as chronic hepatitis B can present challenges as patients age, and the improvements in bone and renal laboratory safety parameters demonstrated by TAF compared to TDF allow it to provide an important new option for patients.”

TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245 mg, but at one-tenth the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes (cells of the liver) compared to TDF, it can be given at a lower dose, which means there is less tenofovir in the bloodstream. By reducing exposure to tenofovir, TAF is associated with improved renal and bone laboratory safety parameters compared to TDF in clinical trials.

“TAF reflects Gilead’s ongoing commitment to improve and simplify care for people with chronic infectious diseases, including hepatitis B, while we continue our research efforts for curative treatments,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We look forward to making TAF available as quickly as possible throughout the European Union.”

TAF’s approval is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) in 1,298 adult chronic HBV patients. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. Both studies met their primary endpoint of non-inferiority to TDF based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy. Patients in the TAF arm of the trials also experienced numerically higher rates of normalization of blood serum alanine aminotransferase (ALT) levels. Both studies showed TAF and TDF to be well-tolerated by patients and discontinuations due to adverse events were 1% and 1.2%, respectively. The most common reported adverse events with TAF were diarrhea, vomiting, nausea, abdominal pain, abdominal distension, flatulence, fatigue, headache, dizziness, rash, pruritus, increased ALT and arthralgia.

While the primary efficacy assessment was performed at week 48, data show that at week 72 viral suppression as well as biochemical responses were maintained with continued TAF treatment. The safety assessment includes analyses performed at both week 48 and week 72 of treatment (median duration of exposure of 88 weeks), and safety endpoints included changes from baseline in bone mineral density at the hip and spine, and changes from baseline in serum creatinine and in eGFR, key indicators of renal health. In both studies, at weeks 48 and 72, changes in renal and bone laboratory safety parameters favored the TAF treatment groups.

Vemlidy was approved by the U.S. Food and Drug Administration on November 10, 2016 for the treatment of chronic HBV infection in adults with compensated liver disease, and by the Japanese Ministry of Health, Labour and Welfare on December 19, 2016 for the suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.

For important safety information for TAF in Europe, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics (SmPC) for Vemlidy, available from the EMA website at http://www.ema.europa.eu. The full prescribing information for TAF in the United States, including BOXED WARNING, is available at www.gilead.com.

Important Safety Information and Indication for Vemlidy in the U.S.

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

    Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs.
    Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Warnings and Precautions

    Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone is not recommended for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
    New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein prior to initiating and during therapy in all patients as clinically appropriate.

Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, fatigue, cough, nausea and back pain.

Drug Interactions

    Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
    Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-gp and BCRP activity may lead to changes in VEMLIDY absorption.

Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

    Dosage: Adults; 1 tablet taken once daily with food.
    Renal Impairment: Not recommended in patients with CrCl <15 mL/min.
    Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
    Testing prior to initiation: HIV infection.

Indication

VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease

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发表于 2017-1-12 08:37 |显示全部帖子
欧洲委员会授权Gilead'sVemlidy®用于治疗乙型肝炎病毒感染

- Vemlidy®是慢性乙型肝炎感染的第一个新的治疗方法在欧盟在近十年内批准 -
2017年1月11日06:53东部标准时间

加利福尼亚州 - (美国商业资讯) - 吉利德科学公司(纳斯达克市场代码:GILD)今天宣布,欧盟委员会已批准Vemlidy®(替诺福韦艾拉酚胺,TAF)的市场授权25毫克,每日一次用于治疗成人和青少年(年龄12岁及以上,体重至少35公斤)的慢性乙型肝炎病毒(HBV)感染。

营销授权允许在欧盟,挪威和冰岛的28个国家销售TAF。

“作为慢性乙型肝炎的第一个新治疗方法,在近十年内将在欧洲获得批准,这项批准标志着一个进步的,危及生命的疾病的管理一个进步,影响1300万欧洲人,”教授,Pietro Lampertico教授说,意大利米兰大学Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico的胃肠病学和肝病学科。 “治疗终身疾病如慢性乙型肝炎可以提出挑战,因为患者年龄,TAF相比TDF显示的骨和肾实验室安全性参数的改善允许它为患者提供一个重要的新选择。

TAF是替诺福韦的新颖的靶向前药,已经证明与Gilead的(替诺福韦地索普西延胡索酸盐,TDF)245mg类似的抗病毒功效,但剂量为十分之一。数据显示,与TDF相比,TAF具有更大的血浆稳定性和更有效地将替诺福韦递送至肝细胞(肝细胞),因此可以以更低的剂量给予,这意味着血流中存在更少的替诺福韦。通过减少暴露于替诺福韦,与临床试验中的TDF相比,TAF与改善的肾和骨实验室安全参数相关。

研究和开发执行副总裁兼首席科学家Norbert Bischofberger博士说:“TAF反映了Gilead一直致力于改善和简化慢性传染病,包括乙型肝炎患者的护理,同时我们继续进行治疗性治疗的研究工作。 ,吉利德科学。 “我们期待在欧盟范围内尽快提供TAF。

TAF的批准由来自两个国际3期研究(研究108和110)的48周数据支持,1,298名成人慢性HBV患者。研究108随机化425名HBeAg阴性患者接受TAF或TDF,研究110随机化873名HBeAg阳性患者接受TAF或TDF。两项研究都基于慢性乙型肝炎患者在48周治疗时血浆HBV DNA水平低于29 IU / mL的患者的百分比满足了其对TDF的非劣效性的主要终点。在试验的TAF组中的患者还经历数值上更高的血清丙氨酸氨基转移酶(ALT)水平的正常化率。两项研究显示,TAF和TDF对患者的耐受性良好,不良事件导致的中断分别为1%和1.2%。 TAF最常见的不良事件是腹泻,呕吐,恶心,腹痛,腹胀,肠胃气胀,疲劳,头痛,眩晕,皮疹,瘙痒,ALT升高和关节痛。

尽管在第48周进行主要功效评价,但数据显示在第72周,通过连续TAF治疗维持病毒抑制以及生化反应。安全性评估包括在治疗的第48周和第72周进行的分析(中值持续时间为88周),安全性终点包括髋部和脊柱骨矿物质密度与基线的变化,以及血清肌酐和在eGFR,肾脏健康的关键指标。在两项研究中,在第48周和72周,肾和骨实验室安全参数的变化有利于TAF治疗组。

Vemlidy由美国食品和药物管理局于2016年11月10日批准用于治疗补偿性肝病患者的慢性HBV感染,并由日本厚生劳动省在2016年12月19日用于抑制病毒复制慢性乙型肝炎患者乙型肝炎病毒复制和异常肝功能的证据。

有关TAF在欧洲的重要安全信息,包括剂量学和管理方法,特殊警告,药物相互作用和不良药物反应,请参阅欧洲Vemlidy产品特性概述(SmPC),可从EMA网站http: www.ema.europa.eu。在美国的TAF的完整处方信息,包括BOXED警告,可在www.gilead.com

美国Vemlidy的重要安全信息和指示

BOXED警告:肝硬化/严重肝硬化与STEATOSIS和治疗后严重急性肝炎的发展B

    已报道使用核苷类似物的乳酸性酸中毒和伴随脂肪变性的严重肝肿大,包括致死病例。
    包括VEMLIDY在内的抗乙型肝炎治疗的停药可能导致乙型肝炎的严重急性加重。在停止抗乙型肝炎治疗的患者中,应对临床和实验室随访至少几个月的肝功能进行密切监测,包括VEMLIDY。如果适当,可能需要恢复抗乙型肝炎治疗。

警告和注意事项

    HBV / HIV-1共感染患者HIV-1耐药的发展风险:由于这种风险,不推荐单独使用VEMLIDY治疗HIV-1感染。在HBV / HIV-1合并感染患者中尚未建立VEMLIDY的安全性和有效性。在开始用VEMLIDY治疗前,应该向所有HBV感染的患者提供HIV抗体检测,如果是阳性,应使用建议用于HBV / HIV-1合并感染患者的合适的抗逆转录病毒组合方案。
    新发病或肾功能衰竭加重:使用替诺福韦前药已报告急性肾衰竭和范康尼综合征的病例。在VEMLIDY的临床试验中,没有Fanconi综合征或近端肾小管病变(PRT)的病例。肾功能受损和/或服用肾毒性剂(包括NSAID)的患者的肾相关不良反应的风险增加。在发生临床显着肾功能下降或Fanconi综合征证据的患者中停用VEMLIDY。
    肾脏监测:在开始治疗前和治疗期间在所有患者中评估血清肌酐,血清磷,CrCl,尿糖和尿蛋白,作为临床适当的。

不良反应

最常见的不良反应(发生率≥5%;所有等级)是头痛,腹痛,疲劳,咳嗽,恶心和背痛。

药物相互作用

    VEMLIDY与降低肾功能或竞争活性肾小管分泌的药物的共同给药可能增加替诺福韦的浓度和不良反应的风险。
    不建议与以下药物联合使用VEMLIDY:奥卡西平,苯巴比妥,苯妥英,利福布汀,利福平,利福喷丁或圣约翰草。预期这种共施用降低替诺福韦艾拉酚胺的浓度,降低VEMLIDY的治疗效果。强烈影响P-gp和BCRP活性的药物可以导致VEMLIDY吸收的变化。

有关可能显着的药物相互作用,包括临床意见的更多信息,请咨询VEMLIDY的完整处方信息。

剂量和管理

    用量:成人; 1片每日服用食物。
    肾损伤:不推荐在CrCl <15 mL / min的患者。
    肝损伤:不推荐在失代偿(Child-Pugh B或C)肝损伤的患者。
    开始前测试:HIV感染。

指示

VEMLIDY用于治疗成年患有补偿性肝病的慢性乙型肝炎病毒(HBV)感染

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发表于 2017-1-12 19:13 |显示全部帖子
BRIEF-European Commission grants marketing authorization for Gilead's Vemlidy (Tenofovir Alafenamide, TAF) for the treatment of chronic hepatitis B virus infection

路透新闻路透新闻2017-01-12 00:11分享
Jan 11 (Reuters) - Gilead Sciences Inc (GILD.O)

* European Commission grants marketing authorization for Gilead's Vemlidy (Tenofovir Alafenamide, TAF) for the treatment of chronic hepatitis B virus infection
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发表于 2017-1-12 19:22 |显示全部帖子
欧洲如期上市,
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发表于 2017-1-12 20:03 |显示全部帖子
Gilead乙肝新药Vemlidy拿下欧洲市场
医药魔方数据2017-01-12 07:37:08乙肝 阅读(30) 评论(0)
声明:本文由入驻搜狐公众平台的作者撰写,除搜狐官方账号外,观点仅代表作者本人,不代表搜狐立场。举报
Gilead 1月11日宣布,欧盟委员会已经批准Vemlidy(替诺福韦艾拉酚胺,TAF)25mg每日1次治疗成人及12岁以上且体重≥35kg青少年慢性乙肝的上市申请。
Vemlidy成为欧洲地区近10年来获准上市的首个乙肝新药。在此之前,Vemlidy已先后获得美国FDA(2016/11/10,见:喜讯!史上最好的乙肝新药Vemlidy(TAF)获批上市)和日本厚生劳动省(2016/12/19,见:Gilead乙肝新药TAF在日本获批)的批准。
TAF是另一款常用乙肝药物Viread(替诺福韦二吡呋酯,TDF)的前药,因为TAF具有较高的血液稳定性,可以有效递达至肝细胞,因此TAF 在剂量低于Viread十分之一(25mg/300mg)的情况下就能发挥与后者相似的疗效,还可避免血液中替诺福韦浓度过高,提高了安全性。
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