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【drug-news】默克公司的新型抗HIV药物获FDA快速审评

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URL of this page: http://www.nlm.nih.gov/medlineplus/news/fullstory_51436.html

FDA grants speedy review for new class of HIV drug
Wednesday, June 27, 2007

NEW YORK (Reuters Health) - U.S. regulators will review Isentress, an investigational drug for HIV infection, on a priority basis, and a decision is anticipated by mid-October, Merck & Co. said on Wednesday.

The oral drug is the first in an HIV drug class called integrase inhibitors. It is generically known as raltegravir, and formerly known as MK-0518. The drug blocks the insertion of HIV's genetic material into human DNA and thereby prevents the virus from replicating. It should be taken twice daily, and can be taken with or without food.

The preliminary results of two phase III trials, presented earlier this year at 14th Annual Retroviral Conference, showed that raltegravir is active against HIV in patients resistant to all three previously approved drug classes for HIV infection.

Merck said the drug, if approved, will be used alongside standard oral HIV drugs by patients who are no longer adequately protected by their current treatments because of viral resistance.

The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.

With priority review status, the U.S. Food and Drug Administration will make its decision on whether to approve the drug within 6 months, rather than the usual 10- to 12-month review period.

Merck tested Isentress in patients who continued to take a standard HIV drug regimen, although they were infected with strains of the virus that had become resistant to at least one drug in each drug class.

Merck added that it is also moving forward with marketing applications for the drug outside of the United States.

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2007-06-29 11:59 浏览 : 1442 回复 : 6

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• 2021.02+中医药单用／联合抗生素治疗社区获得性肺炎临床实践指南

gjyaner

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就是感慨国外的医药发展比我们领先了不知道多少年！

2007-06-29 14:34

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• 笑死，除了妇产只招男性的医院你见过吗？

phoenixcg

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中国的医药都是被国家害得，看看人家印度，中国的工业也只能做做裤子和种点庄稼，顶多也就是仿制仿制，服务业就是造造房子多多剥削剥削！

2007-06-30 12:28

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• 2021中级内科303题目回顾（随时更新）

mengxiaosha

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好久没有来了，惭愧惭愧，拖延了两天，新闻已经变成了旧闻，不好意思。

FDA grants speedy review for new class of HIV drug
FDA承诺对新的艾滋病病毒药物进行特别加速审查
Wednesday, June 27, 2007

NEW YORK (Reuters Health) - U.S. regulators will review Isentress, an investigational drug for HIV infection, on a priority basis, and a decision is anticipated by mid-October, Merck & Co. said on Wednesday.
路透社健康频道纽约报导：默克公司宣布联邦政府将优先协调对于正在研发中的抗艾滋病病毒感染的新型药物的审查，在十月中旬将公布审查结果。
The oral drug is the first in an HIV drug class called integrase inhibitors. It is generically known as raltegravir, and formerly known as MK-0518. The drug blocks the insertion of HIV's genetic material into human DNA and thereby prevents the virus from replicating. It should be taken twice daily, and can be taken with or without food.
这种新型的口服抗艾滋病毒药物属于整合酶抑制剂。通常称为raltegravir，最初被称为MK-0518。这种药物可以有效的阻断艾滋病毒的遗传物质插入到人体DNA中从而使病毒无法进行复制，这种药物需每天服用两次，饭前饭后服用均可。
The preliminary results of two phase III trials, presented earlier this year at 14th Annual Retroviral Conference, showed that raltegravir is active against HIV in patients resistant to all three previously approved drug classes for HIV infection.
三期临床研究的前两个阶段的初步研究结果已于本年度早些时候举行的第十四届逆转录病毒年会上进行了报道，研究结果显示raltegravir 对于那些已对其它三类已知的抗艾滋病毒药物耐药的病例是有效的。
Merck said the drug, if approved, will be used alongside standard oral HIV drugs by patients who are no longer adequately protected by their current treatments because of viral resistance.
默克公司指出如果该药物得到批准之后，将与其它常用的口服药物一起服用，这样可以有效弥补当前应用的药物由于病毒耐药而不能充分发挥药效的不足。
The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.
审查机构承诺将对其优先进行审查，原因在于与目前的治疗药物相比，该药物可能具备显著的优越性能。
With priority review status, the U.S. Food and Drug Administration will make its decision on whether to approve the drug within 6 months, rather than the usual 10- to 12-month review period.
在优先审查过程中，联邦食品药品管理局将在6个月之内作出决定是否批准此药上市，常规的审查过程则需要10到12个月。
Merck tested Isentress in patients who continued to take a standard HIV drug regimen, although they were infected with strains of the virus that had become resistant to at least one drug in each drug class.
默克公司在那些感染了至少对一类已有的治疗药物耐药的病毒的患者中进行了Isentress的药效评估，与此同时这些患者还在服用常规的艾滋病毒治疗药物。
Merck added that it is also moving forward with marketing applications for the drug outside of the United States.
默克公司补充说在美国之外的销售申请也正在积极进展当中。

编译内容：

FDA承诺对新一代艾滋病治疗药物进行特别优先审查

路透社健康频道纽约报道：默克公司宣布联邦政府将优先协调对于其正在研发中的抗艾滋病病毒感染的新型药物的审查，在十月中旬将公布审查结果。这种新型的口服抗艾滋病毒药物属于整合酶抑制剂。通常称为raltegravir，最初被称为MK-0518。这种药物可以有效的阻断艾滋病毒的遗传物质插入到人体DNA中从而使病毒无法进行复制。在那些感染了至少对一类已有的治疗药物耐药的病毒的患者中进行的Isentress的药效评估表明，该药物那些已对其它三类已知的抗艾滋病毒药物耐药的病例是有效的，该结果已于本年度早些时候举行的第十四届逆转录病毒年会上进行了报道。该药物每天口服两次，饭前饭后服用均可。在其获得批准上市以后将与其它常用的口服药物一起服用，这样可以有效弥补当前应用的药物由于病毒耐药而产生的缺陷。基于其所具有的显著的优越性能，FDA承诺将对其优先进行审查，审查期限与常规的10到12个月的审查过程相比大大缩短，将在6个月之内作出决定。默克公司此外还宣称其在海外的销售申请也正在积极进展当中。

2007-07-02 10:29

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mengxiaosha 编辑于 2007-07-02 11:54

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