AbbVie向欧盟提交丙肝鸡尾酒疗法上市许可申请

关键词:AbbVie,丙型肝炎,HCV,鸡尾酒疗法,全口服方案,无干扰素方案

2014年5月9日讯 /生物谷BIOON/ --艾伯维(AbbVie)5月8日宣布,已向欧洲药品管理局(EMA)提交了丙肝鸡尾酒疗法的上市许可申请(MAA),寻求批准用于基因型1(GT1)丙型肝炎病毒(HCV)成人感染者的治疗。此前,EMA已授予该丙肝鸡尾酒疗法加速审批资格。

AbbVie开发的丙肝鸡尾酒疗法是一种全口服、无干扰素方案,由固定剂量ABT-450/ritonavir/ABT-267(150mg/100mg/25mg,每日一次)和ABT-333(250mg,每日2次)有或无利巴韦林(基于体重,每日2次)组成。ABT-450、ABT-267、ABT-333分别具有不同的作用机制,能够中断HCV的复制过程,在不同患者群体中具有优化的持续病毒学应答率。

该丙肝鸡尾酒疗法MAA的提交,是基于迄今为止在慢性基因型1(GT1)HCV患者中开展的最大的全口服、无干扰素III期临床项目的数据。该项目包括6个III期研究,涉及超过25个国家2300多名患者。

在2014年第21届逆转录病毒和机会性感染大会(CROI 2014)上,AbbVie公布的关键III期M13-961(PEARL-III)研究的详实数据表明,其所开发的丙肝鸡尾酒疗法对难治性丙肝群体的治愈率几乎达到了100%。

此外,艾伯维已于今年4月向FDA提交了该丙肝鸡尾酒疗法的新药申请(NDA),FDA曾于2013年5月授予该丙肝鸡尾酒疗法突破性疗法认定。(生物谷Bioon.com)

英文原文:AbbVie files hepatitis C combo in Europe

-- Submission based on the largest Phase III program in genotype 1 (GT1) hepatitis C patients conducted to date[1]

-- European Medicines Agency has granted AbbVie's request for accelerated assessment

NORTH CHICAGO, Illinois, May 8, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) submitted marketing authorization applications (MAAs) to the European Medicines Agency (EMA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The MAAs are supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date[1], which consists of six Phase III studies that include more than 2,300 patients in over 25 countries.

"These regulatory submissions bring us closer to offering adult genotype 1 chronic hepatitis C patients an all-oral, interferon-free regimen which has the potential to provide a promising advancement for the hepatitis C community in the European Union," said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. "This regulatory milestone, on the heels of our submission of a New Drug Application in the U.S., represents an important step for our pipeline."

Accelerated Assessment Granted
The EMA has granted AbbVie's request for accelerated assessment for ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333), a designation that is granted to new medicines of major public health interest. Review of AbbVie's MAAs will be conducted under the centralized licensing procedure which, when finalized, provides one marketing authorization in all 28 member states of the European Union (EU). Although accelerated assessment could shorten the EMA's review time by approximately two months, it does not guarantee a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333) could be available for marketing in the EU in the first quarter of 2015.

Globally, approximately 160 million people are chronically infected with hepatitis C[2] and an estimated 3 million to 4 million people are newly infected each year.[3] In Europe, approximately 17.5 million people have chronic hepatitis C,[4] with GT1 as the predominant genotype.[4]

About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without ribavirin (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.

AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C virus protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

(责任编辑:yangsumin)

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