主页 > 医学动态 >
【drug-news】辉瑞AIDS药物Celsentri获欧洲最后批准
Pfizer AIDS Drug Celsentri Given Final European Approval
Article Date: 09/24/2007
By Laura Vess
Only days after news of the failure of a major Merck HIV vaccine research trial, rival pharmaceutical company Pfizer Inc. has announced the European Commission (EC) approval of the company's AIDS drug, Celsentri, known generically as maraviroc. The drug is the first in a new class of oral HIV medicines in more than a decade.
Maraviroc, discovered and developed by Pfizer in Sandwich, UK, blocks viral entry of the HIV virus into white blood cells. The drug will be available to treatment-experienced HIV patients in the EU in combination with other antiretroviral medications. Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering white blood cells by blocking its predominant entry route, the CCR5 co-receptor, according to a press statement from Pfizer.
“HIV is a significant health concern in Europe and infection rates are still increasing. Without new medicines, resistance to current treatments is one of the biggest challenges facing HIV care today,” said Filippo von Schloesser, president of Italian HIV patient organization, Fondazione Nadir Onlus, in the Pfizer press release. “The approval of maraviroc will offer a new option to many people living with HIV in Europe.”
The EC approval of maraviroc is based on 48-week data from the two ongoing double-blind, placebo-controlled clinical trials. Data from the trials show that the drug, in combination with optimized background therapy (OBT) provides substantially greater viral load reduction compared to OBT therapy alone. In addition, more than twice as many patients receiving maraviroc and OBT in combination achieved an undetectable viral load compared to OBT alone.
“Maraviroc is an important additional treatment option for R5 tropic treatment-experienced patients in Europe,” said Gerd Faetkenheuer, MD, Department of Internal Medicine, University of Cologne, Germany, said in the release. “Although other treatments are currently available, maraviroc targets the fight against the HIV virus in a new way.”
Maraviroc, known as Selzentry in the United States, was approved by the U.S. Food and Drug Administration (FDA) on August 6, 2007 and is currently available in the U.S. Industry analysts have projected annual Celsentri sales of about $500 million by 2011, according to a Reuters report. 本人认领编译本文，48小时内若未提供编译文稿，请其他战友自由认领 Pfizer AIDS Drug Celsentri Given Final European Approval
辉瑞AIDS药物Celsentri获欧洲最后批准
Article Date: 09/24/2007
文章发表日期： 2007年9月24日
By Laura Vess
Onl y days after news of the failure of a major Merck HIV vaccine research trial, rival pharmaceutical company Pfizer Inc. has announced the European Commission (EC) approval of the company's AIDS drug, Celsentri, known generically as maraviroc.
在默克公司一个重要艾滋病疫苗研究试验失败的新闻传出后几天，其竞争对手的辉瑞制药公司宣布：欧洲委员会（欧委会）已经批准该公司通用名为maraviroc，商品名为Celsentri的艾滋病治疗药物可在欧盟范围内上市销售。
The drug is the first in a new class of oral HIV medicines in more than a decade.
该药物是过去十多年来第一种能上市的口服治疗HIV新药。
Maraviroc, discovered and developed by Pfizer in Sandwich, UK, blocks viral entry of the HIV virus into white blood cells.
辉瑞设于英格兰Sandwich的研究中心研究开发的Celsentri能阻止HIV病毒进入白细胞内部。
The drug will be available to treatment-experienced HIV patients in the EU in combination with other antiretroviral medications.
在欧委会范围内，该药可和其它抗逆转录病毒药物合用治疗对其他药物产生了抗药性的艾滋病患者。
Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering white blood cells by blocking its predominant entry route, the CCR5 co-receptor, according to a press statement from Pfizer.
据辉瑞的一份新闻报道称，maraviroc和作用不是遏制白细胞内部的病毒而是通过封闭病毒主要进入途径—CCR5受体发挥作用来防止HIV病毒进入白细胞。
“HIV is a significant health concern in Europe and infection rates are still increasing.
在欧洲，艾滋病是一个重大的健康问题，其感染率仍在增加。
Without new medicines, resistance to current treatments is one of the biggest challenges facing HIV care today,” said Filippo von Schloesser, president of Italian HIV patient organization, Fondazione Nadir Onlus, in the Pfizer press release.
辉瑞新闻报道称意大利Fondazione Nadir Onlus艾滋病患者组织会长Filippo von Schloesser说：“没有新药是目前治疗艾滋病面临的最大挑战。
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-08-12 05:30
医学,生命科学网