FDA专家委员会投票拒绝赛诺菲-安万特减肥药在美上市
By a unanimous vote, a panel of experts convened by the FDA just rejected Sanofi-Aventis’s weight-loss drug, known in Europe as Acomplia, Dow Jones reports.
据道琼斯通讯社报道，由FDA召集的一个专家委员会全票拒绝赛诺菲-安万特公司的减肥药在美上市，该药物在欧洲上市的商品名为Acomplia。
The drug has been approved for sale in Europe but has not been approved here due to concerns over its psychiatric side effects, which include depression and an increased risk of suicidal thoughts. In a presentation to the panel today, Sanofi officials argued that the drug’s risks could be managed by screening out patients with psychiatric problems.
该药物已经在欧洲获准上市，而被拒绝在美国上市的原因是考虑到其精神病学方面的副作用，包括抑郁和增加自杀念头的风险。今天赛诺菲公司人员向专家委员会做陈述时，辩称可通过筛除精神病疾患的病人而得以控制该药物的风险。
The 14-member committee was not persuaded. “There is a reasonable suspicion we better learn more and watch this affair more closely before we launch into massive use of this drug,” said Jules Hirsch, a panel member and professor at Rockefeller University in New York, according to Dow Jones.
由14名成员组成的专家委员会没有被说服。据道琼斯报道，该专家委员会成员、纽约洛克菲勒大学教授Jules Hirsch称：“对此有充分的理由值得怀疑，在大量人群服用该药物之前，我们最好应该对这一副作用有更深入的了解和更进一步的观察。”
While the FDA is not required to follow its committees’ advice, it usually does so. And most observers think the agency, which has previously refused to approve Acomplia because of its side effects, is likely to side with the committee on this one. Sanofi’s stock, which has been falling for more than a week, was down nearly 3% today.
虽然FDA对专家委员会的建议并非为命是从，但通常还是采纳。因此大多数观察家认为，FDA此前曾因副作用而拒绝批准Acomplia，此次也和可能采纳专家委员会的建议。已经持续一周多下跌的赛诺菲公司股票，今天下跌近3%。
Investors Nervous Before Hearing on Sanofi Weight-Loss Drug
投资者焦急等待FDA决定
Sanofi-Aventis’s stock price has been falling steadily in the run-up to today’s FDA advisory committee meeting on the company’s weight-loss drug, sold in Europe as Acomplia and known here as Zimulti, with shares down more than 1.5% yesterday. Analysts feel the market is skeptical that the drug is likely to win approval anytime soon.
今天FDA召集专家委员会就赛诺菲-安万特公司的减肥药物Zimulti（在欧洲市场上称为Acomplia）进行咨询，此前该公司股票价格持续下跌，昨天下跌1.5%之多。分析家认为，证券市场对该药物近期获得批准持怀疑态度。
“At current levels we would take profits ahead of the Zimulti panel meeting,” said analysts at Bear Stearns, according to Dow Jones. “Further delays regarding Zimulti’s approval in the U.S. are likely.”
据道琼斯通讯社消息，贝尔史登公司(Bear Stearns)分析家称：“此时，在Zimulti专家委员会开会之前，我们应该收回赢利，出市走人。Zimulti在美国获准上市很可能继续推迟。”
Earlier this week, briefing documents the FDA posted online in advance of the meeting suggested the drug raises the risk of suicidal thoughts. The documents also reported a high rate of other psychiatric side effects, such as depression and anxiety, which have been reported among patients taking the drug in Europe. The documents did say that the drug helps obese patients lose weight, and Sanofi has proposed a plan to limit the drug’s psychological risks.
本周早些时候，FDA在专家委员会会议之前，在其网站上刊登了有关该药物增加自杀念头风险的简报。该简报还报告了其它精神方面的副作用的高发生率，如抑郁和焦虑。在欧洲服用该药物的患者中，这些副作用已经有所报告。该简报也确实称该药物可助于肥胖患者减轻体重，并称赛诺菲公司已经提交了一项限制该药物精神方面的风险的计划。
The meeting began early this morning and is scheduled to run through the day. The FDA has asked the committee ― whose members are listed here ― to vote on several key questions (listed here), including whether the drug increases the risk of psychological problems, whether the benefits of the drug outweigh the risks, and whether, if the drug is approved, it should carry specific warnings. We’ll be following the hearing throughout the day and will post later on how the committee answers those questions.
专家委员会会议是从今天上午开始的，按计划将持续全天。FDA要求该委员会就几个关键问题进行表决，这包括该药物是否提高精神疾患的风险、受益是否大于风险、如果获得批准，是否需要附加特别警示。我们将全天观其进展，并将委员会的意见及时公布。
编译：
据道琼斯通讯社报道，由FDA召集的一个专家委员会全票拒绝赛诺菲-安万特公司的减肥药在美上市，该药物在欧洲上市的商品名为Acomplia。
该药物已经在欧洲获准上市，而被拒绝在美国上市的原因是考虑到其精神病学方面的副作用，包括抑郁和增加自杀念头的风险。今天赛诺菲公司人员向专家委员会做陈述时，辩称可通过筛除精神病疾患的病人而得以控制该药物的风险。但由14名成员组成的专家委员会没有被说服。该专家委员会成员、纽约洛克菲勒大学教授Jules Hirsch称，对此他们有充分的理由表示怀疑，所以在大量人群服用该药物之前，最好应该对这一副作用有更深入的了解和更进一步的观察。
虽然FDA对专家委员会的建议并非为命是从，但通常还是采纳。因此大多数观察家认为，FDA此前曾因副作用而拒绝批准Acomplia，此次也很可能采纳专家委员会的建议。已经持续一周多下跌的赛诺菲公司股票，今天下跌近3%。
道琼斯通讯社消息，今天FDA召集专家委员会就赛诺菲-安万特公司的减肥药物Zimulti（在欧洲市场上称为Acomplia）进行咨询，此前该公司股票价格持续下跌，昨天下跌1.5%之多。分析家认为，证券市场对该药物近期获得批准持怀疑态度。
贝尔史登公司(Bear Stearns)分析家称，在Zimulti专家委员会开会之前，他们应该收回赢利，出市走人，因为Zimulti在美国获准上市的时间很可能继续推迟。
在专家委员会举行会议之前的本周早些时候，FDA在其网站上刊登了有关该药物增加自杀念头风险的简报。该简报还报告了其它精神方面的副作用的高发生率，如抑郁和焦虑。在欧洲服用该药物的患者中，这些副作用已经有所报告。该简报也确实称该药物可助于肥胖患者减轻体重，并称赛诺菲公司已经提交了一项限制该药物精神方面的风险的计划。
专家委员会会议是从今天上午开始的，按计划将持续全天。FDA要求该委员会就几个关键问题进行表决，这些问题包括该药物是否提高精神疾患的风险、受益是否大于风险、如果获得批准，是否需要附加特别警示等。记者称，他们将全天观其进展，并将委员会的意见及时公布。
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