FDA扩大了AbbVie的Mavyret标签范围，纳入急性丙型肝炎治疗（已更正）-动脉网

FDA Expands AbbVie's Mavyret Label To Include Acute Hepatitis C Treatment (CORRECTED)

benzinga 等信源发布 2025-06-11 17:07

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Editor's Note: This headline and story have been updated to clarify that the FDA approval was for an expanded indication to treat acute HCV.

编辑注：标题和文章已更新，以澄清FDA批准的是用于治疗急性丙型肝炎的扩展适应症。

The U.S. Food and Drug Administration (FDA) approved a label expansion for

美国食品和药物管理局 (FDA) 批准了标签扩展

AbbVie Inc

艾伯维公司

的

ABBV

艾伯维

Mavyret (glecaprevir/pibrentasvir) to include treatment of acute hepatitis C virus (HCV) infection in patients without cirrhosis

Mavyret（格列卡普韦/匹布他司韦）可用于治疗无肝硬化的急性丙型肝炎病毒（HCV）感染患者。

or with compensated cirrhosis.

或伴有代偿性肝硬化。

Glecaprevir, one of the two DAAs in Mavyret, was Discovered by

格列卡普韦（Glecaprevir），Mavyret中的两种DAAs之一，被发现于

Enanta Pharmaceuticals, Inc

恩anta制药公司

ENTA

and developed and commercialized by AbbVie.

由AbbVie开发并商业化。

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With this approval, Mavyret is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate.

通过此项批准，Mavyret 成为首个也是唯一一个在八周内治疗急性丙型肝炎病毒（HCV）患者且治愈率达96%的直接抗病毒药物（DAA）疗法。

HCV is a highly infectious blood-borne

HCV是一种高传染性的血源性病原体

disease affecting the liver

影响肝脏的疾病

。

The United States is expected to incur around $120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV.

预计美国在未来10年到2035年期间，因未经治疗的丙型肝炎引发的慢性肝病及其他相关疾病，将产生约1200亿美元的总医疗费用。

Data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of Mavyret eight-week treatment in adults with acute HCV infection supported the label expansion.

来自评估Mavyret八周治疗方案在急性丙型肝炎病毒（HCV）感染成人患者中的安全性和有效性的第3期、多中心、单臂前瞻性研究的数据支持了标签扩展。

The study results showed Mavyret to be a highly efficacious treatment for people with acute HCV.

研究结果显示，Mavyret 对急性丙型肝炎患者的治疗效果非常显著。

The majority of the adverse events reported were mild or moderate in severity. Fatigue, asthenia, headache, and diarrhea were the most common adverse events.

报告的大多数不良事件严重程度为轻度或中度。疲劳、虚弱、头痛和腹泻是最常见的不良事件。

In 2017, the FDA approved Mavyret to

2017年，FDA批准了Mavyret

treat

对待

adults with chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infections without cirrhosis or with compensated cirrhosis.

慢性（长期）丙型肝炎病毒（HCV）基因型1、2、3、4、5或6感染的成人，无肝硬化或有代偿性肝硬化。

In 2019, the FDA approved Mavyret 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).

2019年，FDA批准Mavyret将既往未接受治疗、代偿性肝硬化、慢性丙型肝炎（HCV）患者（覆盖所有基因型GT1-6）的每日一次治疗周期从12周缩短至8周。

Price Action:

价格行为:

ABBV stock is trading higher by 1.54% to $192.43 at last check Wednesday.

ABBV股票在周三最后一次检查时上涨了1.54%，达到192.43美元。

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