EMA授予勃林格丙肝药物faldaprevir加速评估

勃林格殷格翰（Boehringer Ingelheim）11月26日宣布，欧洲药品管理局（EMA）已授予实验性丙型肝炎药物faldaprevir加速评估（accelerated assessment），该药是一种强效的新一代口服蛋白酶抑制剂，目前正开发与聚乙二醇干扰素和利巴韦林（PegIFN/RBV）联合用于广泛的基因型1（GT-1）丙型肝炎患者群体的治疗，包括难治性群体，如HCV-HIV共感染群体及晚期肝病群体。

医药产品的加速评估，主要是出于公众健康和治疗创新的角度考虑，并不意味着一定获得欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见，抑或欧盟委员会（EC）的批准。

若faldaprevir上市许可申请（MAA）获得批准，勃林格殷格翰计划于2014年下半年在欧洲推出该药。

faldaprevir MAA的提交，是基于一项全面的临床开发项目，尤其是一项III期STARTVerso临床试验的数据，这些研究数据证明了faldaprevir+PegIFN/RBV在广泛基因型1（GT-1）丙型肝炎患者群体中的疗效和安全性。

英文原文：Hepatitis C: Boehringer Ingelheim’s faldaprevir granted accelerated assessment from European Medicines Agency

--Accelerated assessment reserved for medicinal products of major interest from the viewpoint of public health and therapeutic innovation

--Submission based on comprehensive development programme including the Phase III STARTVerso™ data aiming to demonstrate the efficacy and safety of faldaprevir* + PegIFN/RBV in a broad range of genotype-1 infected hepatitis C patients

INGELHEIM, 26 November, 2013 – The application for European marketing authorisation of faldaprevir*, a potent second generation oral protease inhibitor, has been fully validated and granted accelerated assessment by the European Medicines Agency (EMA).5,6 Boehringer Ingelheim is seeking marketing approval of faldaprevir* in combination with pegylated interferon and ribavirin (PegIFN/RBV) for the treatment of a broad range of patients with genotype-1 (GT-1) hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease.

Accelerated assessment status does not automatically lead to a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) or the granting of a marketing authorization by the European Commission.1 If approved by the European Commission, faldaprevir* could be available for marketing in the EU in the second half of 2014.

The EMA Marketing Authorisation Application is based on a comprehensive clinical development programme for faldaprevir* with a particular focus on the Phase III STARTVerso™ trial data, recently presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). These studies include data for faldaprevir* in:

Treatment naïve patients with the majority having benefited from shorter treatment duration and achieved viral cure2
Difficult-to-cure patient populations such as those with HIV co-infection4 or advanced liver disease2,3
Patients with the Q80K polymorphism (this mutation is considered to affect the efficacy of other second generation protease inhibitors)2
Treatment experienced patients who have relapsed,  partially responded or failed to respond to previous therapy3

Faldaprevir* is the foundation of Boehringer Ingelheim’s hepatitis C treatment pipeline and is being developed in combinations both with and without interferon. In addition to the interferon-based faldaprevir* regimen that has been submitted for marketing approval, Boehringer Ingelheim aims to deliver one of the first interferon-free regimens for the treatment of hepatitis C infection. The goal is to make an interferon-free future a reality for a broad range of hepatitis C patients. Pivotal Phase III HCVerso® data for the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin will be available in 2014.