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【drug-news】脑部感染重现MS药物Tysabri
Brain Infections Return for Multiple Sclerosis Drug Tysabri
Posted by Jacob Goldstein
Two patients taking the multiple sclerosis drug Tysabri have developed the type of brain infection that caused the drug to be temporarily pulled from the market a few years back.
Biogen Idec and Elan, which co-market the drug, reported the cases of progressive multifocal leukoencephalopathy in SEC filings yesterday.
These are the first cases of PML that have emerged since the drug was taken off the market in 2005 after three patients in clinical trials developed PML, and two died from the infection. (Two of the patients had MS; a third had Crohn’s, which the drug is also approved for.)
Both new cases were diagnosed this week in the EU. One patient, who had been taking Tysabri for 17 months, is now “clinically stable and ambulatory at home,” the SEC filing said. That patient had not taken other MS drugs. The other patient, on the drug for 14 months, is hospitalized and had previously taken other MS drugs.
U.S.-traded ADRs of Elan were down more than 40% in pre-market trading this morning, and Biogen was down more than 20%. It’s the second gut-punch in a week for Elan investors. Disappointing data on an experimental Alzheimer’s treatment Wyeth and Elan are developing clipped about 30% from Elan’s value.
More than 30,000 people take Tysabri, and the companies have said all along that a small risk of PML remains associated with the drug. Analysts have been impressed with how many patients have returned to Tysabri since it went back on the market.
The drug will probably remain on the market despite the new cases, the WSJ suggests. That means patients and their doctors will face a potentially difficult decision: Weighing the benefits and risks of a drug that eases the burden of MS but slightly increases the risk of developing a second illness. 请诸位战友校对，纠错哈～
August 1, 2008, 8:25 am
Brain Infections Return for Multiple Sclerosis Drug Tysabri
Posted by Jacob Goldstein
多发性硬化症药物－Tysabri 再次引发脑部感染
Two patients taking the multiple sclerosis drug Tysabri have developed the type of brain infection that caused the drug to be temporarily pulled from the market a few years back.
两名服用多发性硬化症治疗药Tysabri的患者出现脑部感染，数年前曾因脑部感染问题而使该药临时撤出市场。
Biogen Idec and Elan, which co-market the drug, reported the cases of progressive multifocal leukoencephalopathy in SEC filings yesterday.
昨天，共同推出该药的Biogen Idec 和Elan公司在给SEC(美国证券委员会)的文件中报告了进行性多灶脑白质病（PML）病例情况。
These are the first cases of PML that have emerged since the drug was taken off the market in 2005 after three patients in clinical trials developed PML, and two died from the infection. (Two of the patients had MS; a third had Crohn’s, which the drug is also approved for.)
在临床试验中曾有三名患者出现PML，其中两名因感染而死，因此该药被撤出市场。这是该药自2005年撤出市场后的首批PML病例。（临床试验中的三名患者其中两名患有MS；另一名患有克隆病－该药的另一种适应症。）
Both new cases were diagnosed this week in the EU. One patient, who had been taking Tysabri for 17 months, is now “clinically stable and ambulatory at home,” the SEC filing said. That patient had not taken other MS drugs. The other patient, on the drug for 14 months, is hospitalized and had previously taken other MS drugs.
本周新确诊的两例患者均位于欧盟。SEC文件称，其中一名患者服用Tysabri 17个月，目前“在家休养，临床症状稳定，可下床活动”。该患者并未服用其他MS药物。而另一名患者服药14个月，目前正在住院治疗，之前曾服用其他MS药物。
U.S.-traded ADRs of Elan were down more than 40% in pre-market trading this morning, and Biogen was down more than 20%. It’s the second gut-punch in a week for Elan investors. Disappointing data on an experimental Alzheimer’s treatment Wyeth and Elan are developing clipped about 30% from Elan’s value.
在今天早上的开市前交易中，Elan的ADR（美国储蓄证券）交易价下跌40％以上，Biogen下跌20％以上。对Elan的投资者来说，这是本周第二次重创。Elan公司的老年痴呆治疗药Wyeth 实验数据不容乐观，使Elan股价下跌约30％。
More than 30,000 people take Tysabri, and the companies have said all along that a small risk of PML remains associated with the drug. Analysts have been impressed with 编译：（中文字符：467）
昨天，共同推出多发性硬化症（MS）治疗药Tysabri的Biogen Idec 和Elan公司在给SEC(美国证券委员会)的文件中报告了进行性多灶脑白质病（PML）病例情况：两名服用Tysabri的患者出现脑部感染。数年前Tysabri曾因脑部感染问题而被临时撤出市场。
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作者:admin@医学,生命科学 2011-06-12 05:14
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