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【drug-news】FDA批准了只需每日服用一粒的艾滋病
By ANDREW POLLACK
Published: July 13, 2006
The first drug that allows AIDS to be treated by taking one pill a day won federal approval yesterday, a development that government officials said would both simplify and improve treatment of the disease.
The drug, called Atripla, is a combination of three once-a-day drugs that are already on the market — Sustiva from Bristol-Myers Squibb, and Viread and Emtriva from Gilead Sciences.
Only a decade ago, when cocktails of AIDS drugs began to be used, patients sometimes had to take two dozen or more pills a day.
Atripla, which will be available this week or next, will have a wholesale price of $1,150 a month, equal to the sum of the prices of its components, James Loduca, a spokesman for Gilead, said.
Both Gilead and Bristol-Myers will market the drug.
The approval by the Food and Drug Administration yesterday, which was expected, came well before the October deadline for the agency to act. F.D.A. officials said they moved quickly because a once-a-day treatment would help people take their medicines faithfully. That would prevent the AIDS virus from gaining resistance to the drugs.
“It’s one thing to have medicine available, but it will only be effective when people can indeed take it as they are supposed to,” Dr. Murray M. Lumpkin, an F.D.A. deputy commissioner, said at a news conference in Washington. Dr. Lumpkin said a once-a-day treatment would be particularly important for developing countries, where access to health care is more limited.
Yet no announcement was made yesterday about when the drug would be available overseas and for what price. An agreement must first be reached with Merck & Company, which sells Sustiva, also known as efavirenz, in developing countries under the name Stocrin.
Jeffrey Sturchio, vice president for external affairs at Merck, said his company had “reached agreement on all the issues with Gilead.” He said it was now a matter of formalizing the agreement and then applying for approval in various countries.
He predicted that Atripla would be available in some poor countries in the next several months at a price that would be roughly the sum of the heavily discounted prices at which the component drugs are now sold in those places.
Gilead, based in Foster City, Calif., has become one of the most successful biotechnology companies, based on its AIDS drugs, which accounted for $1.4 billion of its $2 billion in revenue last year. One of its big sellers is Truvada, a once-a-day combination of Viread, also known as tenofovir, and Emtriva, also known as emtricitabine. Truvada is usually taken with another drug, like Bristol-Myers’s Sustiva.
Yaron Werber, an analyst at Citigroup, which counts Gilead as a client, said that adding the Bristol-Myers drug into a three-drug combination pill would allow Gilead to take market share from GlaxoSmithKline, which sells a popular two-drug combination called Combivir.
“I think the drug will do exceptionally well,” Mr. Werber said of Atripla. “The drug is now the most convenient on the market and it’s probably also the most potent.”
源文档 <http://www.nytimes.com/2006/07/13/business/13drug.html>
FDA批准了只需每日服用一粒的艾滋病治疗药丸
昨天，第一种每日仅服用一粒的艾滋病治疗药物通过了联邦政府的批准。政府官员称这一进展将简化并改进对于艾滋病的治疗方法。
这种称为Atripla的药物是市面上已有的三种药物(每天一次服用)的复方组合，这三种药物分别是Bristol-Myers Squibb公司的Sustiva(依法维仑)和Gilead Science公司的Viread（替诺福韦酯）和Emtriva（恩曲他宾）。
仅仅在十年前，当治疗艾滋病的鸡尾酒疗法开始使用的时候，病人有时必须每天服下
两打甚至更多的药片。
Gilead公司发言人James Loduca宣称，Atripla将于近两周内上市销售，其批发价格为每月1,150美元，相当于其三种组成药物（Sustiva，Viread和Emtriva）的总和。而Gilead和Bristol-Myers Squibb公司都将销售这种药物。
FDA昨天刚刚通过了这一令人期待的批准，并且恰好赶在受理截止期限的十月前通过。FDA的官员称他们加快了受理速度因为这种一天一粒的治疗方法将有助于病人按时吃药，而这将减少艾滋病病毒耐药性的产生。
“得到药物是一回事，而能否取得治疗效果则依赖于人们是否按照要求服用了药物”，
FDA的一位副理事，Dr. Murray M. Lumpkin博士在华盛顿的一次新闻发布会上说，一天一粒的治疗方法对于发展中国家将尤为重要，在那些地方（艾滋病的治疗手段）更加有限。
然而昨天并没有同时宣布这种药物在海外上市的时间和价格，因为在这之前还需要一份和Merck公司的合约。Merck公司负责销售Sustiva，又名efavirenz，在发展中国家则被称作Stocrin。Merk公司负责外部事务的副主席Jeffrey Sturchio称他们公司“已经在在所有条款上和Gilead公司达成了一致”，目前只剩下将合约书面化同时寻求在其他国家通过（这一药物）的使用批准。他预计Atripla将于数月后在一些贫困国家上市，价格大致为在这些国家低价打折销售的各个组成药物的总和。
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作者:admin@医学,生命科学 2011-02-19 05:21
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