艾伯维（AbbVie）获得MAVYRET®（glecaprevir / pibrentasvir）的FDA批准

StephenW

AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes

- MAVYRET® (glecaprevir/pibrentasvir) is now available as the only 8-week pan-genotypic treatment option for treatment-naïve chronic hepatitis C (HCV) patients, without cirrhosis or with compensated cirrhosis*

- FDA approval is supported by an overall 98 percent cure** rate across this patient population[1]

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AbbVie

Sep 26, 2019, 20:00 ET

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NORTH CHICAGO, Ill., Sept. 26, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has granted approval of MAVYRET® ( Glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6). In August 2017, MAVYRET received regulatory approval in The US as an 8-week, pan-genotypic treatment for treatment-naïve HCV patients without cirrhosis.

"While over 100,000 patients have been prescribed MAVYRET for chronic HCV in the US‡, there are still a significant number of patients that need options," said Janet Hammond, MD, Ph.D., vice president, general medicine and virology therapeutic area , AbbVie. "This approval provides more HCV patients an option to treat their disease in as little as 8 weeks."

The label expansion was based on data from the Phase 3b EXPEDITION-8 study, a single-arm, open-label study evaluating the safety and efficacy of MAVYRET in treatment-naïve adults with GT1-6 chronic HCV and compensated cirrhosis. In the study , an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatment (SVR12).1

"With more than 2.3 million people in the United States still living with chronic HCV, access to shorter-term, 8-week treatment options can help us move closer to achieving the World Health Organization's goal of elimination HCV by 2030," said Robert S Brown, Jr., MD, Gladys and Roland Harriman professor of medicine, Weill Cornell Medical College.

In EXPEDITION-8, a single relapse out of 336 patients treated was reported and no patients discontinued treatment due to adverse events.1,2 The adverse reactions reported in greater than or equal to 5 percent of compensated cirrhotic patients (n=343) were Fatigue (8%), pruritus (7%), and headache (6%).1 Data from cohort one (GT1,2,4,5,6) was presented last year at The Liver Meeting® 2018 organized by the American Association For the Study of Liver Diseases (AASLD), and data from cohort two (GT3) will be presented at an upcoming medical meeting.

About the EXPEDITION-8 Study1,2
EXPEDITION-8 is a single-arm, open-label, Phase 3b study in treatment-naïve, GT1-6 chronic HCV patients with compensated cirrhosis (n=343) who received MAVYRET for 8 weeks.

The primary endpoints are the sustained virologic response 12 weeks after treatment (SVR12) rates in patients across all genotypes in a per-protocol (PP) and intent-to-treat (ITT) population versus respective historical SVR12 rates based on the efficacy of MAVYRET For 12 weeks in treatment-naïve patients with compensated cirrhosis. The key secondary efficacy endpoints are the percentages of GT1- 6 patients achieving SVR12 in a PP and ITT population.

Additional information on the clinical trials for MAVYRET is available at www.clinicaltrials.gov/.

About MAVYRET® (glecaprevir/pibrentasvir)1
MAVYRET® is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).

MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed as three tablets taken at the same time once daily With food.

</br><br><br><br><br> GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET Is a pan-genotypic treatment approved for use in patients across all stages of CKD.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

StephenW

艾伯维（AbbVie）获得MAVYRET®（glecaprevir / pibrentasvir）的FDA批准，可将初治的慢性丙型肝炎和所有基因型代偿性肝硬化患者的治疗时间缩短至八周

-MAVYRET®（glecaprevir / pibrentasvir）现在可作为无肝硬化或代偿性肝硬化的未经治疗的慢性丙型肝炎（HCV）患者的唯一8周泛基因型治疗选择*

-该患者人群的总治愈率98％**支持FDA批准[1]

新闻提供者
艾伯维

美国东部时间2019年9月26日20:00

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伊利诺斯州北芝加哥，2019年9月26日/美通社/-研究型全球生物制药公司AbbVie（纽约证券交易所代码：ABBV）今天宣布，美国食品药品监督管理局（FDA）已批准MAVYRET®（ Glecaprevir / pibrentasvir）可将所有基因型（GT1-6）的初治，代偿性肝硬化，慢性丙型肝炎（HCV）患者的每日治疗时间从12周缩短至8周。 2017年8月，MAVYRET在美国获得了监管机构的批准，作为为期8天的无肝硬化初治HCV患者的全基因型治疗。

“虽然在美国已为超过100,000名患者开具了用于慢性HCV的MAVYRET处方，但仍有大量患者需要选择，”普通医学和病毒学治疗领域副总裁Janet Hammond博士说，艾伯维。 “这项批准为更多的HCV患者提供了在短短8周内治疗其疾病的选择。”

标签扩展基于3b期EXPEDITION-8研究的数据，该研究是一项单臂，开放标签的研究，评估了MAVYRET在未接受过治疗的GT1-6慢性HCV和代偿性肝硬化成人中的安全性和有效性。在该研究中，总体有98％（n = 335/343）的患者在治疗后12周（SVR12）获得了持续的病毒学应答。1

Robert S说：“在美国，仍有230万人患有慢性HCV，获得短期，为期8周的治疗选择可以帮助我们更加接近实现世界卫生组织到2030年消除HCV的目标。”威尔·康奈尔医学院，小布朗，医学博士，格拉迪斯和罗兰·哈里曼医学教授。

在EXPEDITION-8中，报告了336名接受治疗的患者中仅有一次复发，并且没有患者因不良事件而中止治疗。1,2报道的大于或等于5％的肝硬化代偿患者（n = 343）的不良反应为疲劳（8％），瘙痒（7％）和头痛（6％）。1去年在美国协会举办的The LiverMeeting®2018大会上展示了第一组的数据（GT1,2,4,5,6）对于肝病研究（AASLD），第二组（GT3）的数据将在即将举行的医学会议上发表。

关于EXPEDITION-8研究1,2
EXPEDITION-8是一项单臂，开放标签的3b期研究，用于未接受过GT1-6肝硬化治疗的初治GT1-6慢性HCV患者（n = 343），接受了MAVYRET治疗8周。

主要终点是按方案（PP）和意向治疗（ITT）人群中所有基因型的患者在治疗后12周（SVR12）的持续病毒学应答率与基于MAVYRET疗效的历史SVR12比率之比在未接受过治疗的肝硬化患者中治疗12周。次要疗效的关键终点是PP和ITT人群中GT1-6患者达到SVR12的百分比。

有关MAVYRET临床试验的更多信息，请访问www.clinicaltrials.gov/。

关于MAVYRET®（glecaprevir / pibrentasvir）1
MAVYRET®已获得美国食品药品监督管理局（FDA）的批准，可用于治疗成人所有主要基因型（GT1-6）的慢性丙型肝炎病毒（HCV）感染。

MAVYRET是一种全基因型，每日一次，无利巴韦林的治疗药物，将格列卡韦（100mg）（一种NS3 / 4A蛋白酶抑制剂）和匹布那韦（40mg）（一种NS5A抑制剂）联合使用，分为三片，每天一次，同时服用带着食物。

</br> <br> <br> <br> <br> GT1）不能通过既往治疗经验治愈过蛋白酶抑制剂或NS5A抑制剂（但不能同时使用），并且在治疗选择有限的患者中（例如重度慢性肾脏病（CKD）或具有3型慢性HCV基因型的人。 MAVYRET是一种泛基因型治疗药物，已批准用于CKD所有阶段的患者。

在AbbVie与Enanta Pharmaceuticals（纳斯达克股票代码：ENTA）之间正在进行的合作中，发现了丙戊酸（GLE）用于HCV蛋白酶抑制剂和包括蛋白酶抑制剂的治疗方案。