CHMP建议批准ViiV HIV新药Tivicay

2013年11月25日讯 /生物谷BIOON/ --葛兰素史克（GSK）和辉瑞（Pfizer）合资公司ViiV Healthcare 11月21日宣布，HIV新药Tivicay（dolutegravir，50mg片剂）上市许可申请（MAA）获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准Tivicay联合其他抗逆转录病毒药物用于HIV成人感染者和12岁以上青少年感染者的治疗。

CHMP的积极意见，是基于dolutegravir的4个关键性III期临床试验（SPRING-2、SINGLE、SAILING、VIKING-3）的安全性和疗效数据。欧盟委员会（EC）预计将于2014年早些时候做出审查决定。

此前，Tivicay已分别于2013年8月和10月获FDA和加拿大卫生部批准，与其他抗逆转录病毒制剂联合用于既往已治疗过、或初治HIV-1成人和12岁及以上体重至少40千克儿童感染者。

关于Tivicay（dolutegravir）：

Tivicay为每日一次的口服药物，是HIV整合酶抑制剂，旨在与其他抗逆转录病毒制剂联合用于既往已治疗过、或初治HIV-1成人和12岁及以上体重至少40千克儿童感染者。

关于III期临床项目：

SPRING-2：在822例HIV感染者中开展，评价了每天1次Tivicay与每天2次raltegravir（拉替拉韦）与一种固定剂量双NRTI疗法联合治疗的疗效。48周时，含Tivicay方案有88%的患者实现病毒学抑制（HIV-1 RNA<50 c/ml），含raltegravir方案为86%，达到了10%的非劣性标准。

SINGLE：在833例初治HIV感染者中开展，评价了每天1次Tivicay+阿巴卡韦/拉米夫定相对于单一片剂Atripla的疗效。48周时，含Tivicay方案有88%的患者实现病毒学抑制（HIV-1 RNA<50 c/ml），Atripla方案为81%，数据具有统计学显着差异。Tivicay方案组有2%患者因不良事件中止治疗，Atripla方案组为10%。

SAILING：在719例经当前疗法治疗失败但未使用整合酶抑制剂治疗的患者中开展，评价了每天1次Tivicay和每天2次raltegravir（拉替拉韦）结合一种背景方案（2种制剂，其中至少1种完全活性剂）的疗效。24周时，含Tivicay方案有79%的患者实现病毒学抑制（HIV-1 RNA<50 c/ml），含raltegravir方案为70%，数据具有统计学显着差异。

VIKING-3：在183例正在接受治疗、且HIV已对数类HIV药物（包括整合酶抑制剂雷特格韦和/或elvitegravir）的成人感染者中开展。该项研究中，背景方案中添加Tivicay治疗7天后，HIV RNA水平下降达1.4 log10 c/ml。24周时，添加Tivicay方案有63%的患者实现病毒学抑制（HIV-1 RNA<50 c/ml）。

Tivicay用于12岁及以上、体重至少40千克儿童的适应症申请，是基于一项多中心、开发标签试验的安全性、药代动力学、药效评价数据。该项研究在既往未接受过整合酶抑制剂治疗的患者中开展。

关于ViiV Healthcare：

ViiV医疗保健公司是葛兰素史克（GSK）和辉瑞（Pfizer）于2009年联合成立的HIV/AIDS药物研发公司，目前，GSK持有ViiV 76.5%的股份，辉瑞持有10%的股份，日本盐野义（Shionogi）持有10%的股份。（生物谷Bioon.com）

英文原文：Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV

London, UK, 21 November 2013

ViiV Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Tivicay® (dolutegravir) for use in combination with other antiretroviral medicinal products for the treatment of HIV-infected adults and adolescents above 12 years of age.

“We welcome the CHMP’s positive opinion on dolutegravir – it puts us a step closer to offering this new treatment option to people across Europe who are living with HIV,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “We are committed to research that seeks to make advances in treatment options for people living with HIV. To make progress, thousands of patients have supported us through their participation in clinical development work and we recognise their commitment today with great gratitude.”

The CHMP opinion is based on safety and efficacy data for dolutegravir from four pivotal Phase III studies1-4. These involved people living with HIV who were new to treatment and also those with prior experience of treatment, and included comparators representing antiretroviral treatments commonly used today in the battle against HIV.  More than 2,500 people were treated across these studies, and the regulatory submission also included data in children aged 12 years and older.

A CHMP positive opinion is one of the final steps in the regulatory process leading to the marketing authorisation decision of the European Commission, which is expected early in 2014.

About Tivicay® (dolutegravir)

Tivicay® was approved by the U.S. FDA in August 2013 and by Health Canada in October 2013 – please refer to local labelling for more information. It is a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

Regulatory applications are being evaluated in other countries worldwide. Regulatory applications for ViiV Healthcare’s developmental single-tablet regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine) were submitted to regulatory authorities in Europe, Canada and the U.S. in October 2013.