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FDA工作人员质疑抗血栓药semuloparin的价值

来源:环球医学编译    时间:2012年06月20日    点击数:    5星

6月20日消息 - 环球医学据悉,美国药物审评人员质疑赛诺菲SA的semuloparin注射剂用于化疗中癌症患者预防血栓的价值。

食品和药物管理局的工作人员说,在semuloparin的临床试验中,只有少数人实际上有血栓问题,大多数人死于其他问题。

“这些研究结果对在推荐临床条件下应用semuloparin的临床价值提出了质疑,”FDA评审人员在周一在线发布的文件中说。

FDA先进行工作人员审查,然后再进行顾问小组审查,后者将在在周三投票决定是否推荐semuloparin。尽管并非必须,但FDA通常会遵循顾问小组的建议,FDA将在稍后做出最终决定。

赛诺菲表示,癌症患者接受化疗时的血栓风险是非癌症患者的6.5倍。

但FDA的工作人员称,数据显示血栓发生率仍然很低——在服用安慰剂者中,只有3.4%的人在试验期间出现了血栓。

与此同时,约5%的患者死于其他原因,这增加了关于癌症患者预防血栓的重要性的疑惑。

与安慰剂相比,Semuloparin还与较高的出血风险相关,在服用该药的患者中,约有1/5的人出现了出血问题,其中包括重要部位和器官的出血。

法国制药商赛诺菲在巴黎证券交易所的股价上涨了约0.1%,报收于56.26欧元,而在CAC 40指数中则下跌了0.6%。(环球医学)

原文:

FDA staff question value of Sanofi blood clot drug

U.S. drug reviewers questioned the value of preventing blood clots with Sanofi SA's semuloparin injection for cancer patients receiving chemotherapy.

The Food and Drug Administration staff said only a small number of people in the clinical trials for semuloparin actually had issues with clotting, and most people died from other problems.

"These findings call into question the clinical value of semuloparin in the proposed clinical setting," the FDA reviewers said in documents posted online on Monday.

The FDA staff review comes ahead of an advisory panel, which will vote on whether to recommend semuloparin on Wednesday. The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later.

Sanofi has said cancer patients getting chemotherapy have a 6.5 times higher risk of getting blood clots than patients without cancer.

But the FDA staff said data showed the rate was still very low, as only 3.4 percent of people who took a placebo during the clinical trial had a blood clot.

At the same time, about 5 percent of patients died from other causes, raising doubts about the importance of preventing blood clots in cancer patients.

Semuloparin was also tied to a higher risk of bleeding compared with placebo, with about a fifth of patients having some bleeding issues while taking the drug, including bleeding into a critical area or organ.

Shares of French drugmaker Sanofi were up about 0.1 percent at 56.26 euros on the Paris stock exchange, compared with a 0.6 percent fall in the CAC 40 Index.
 

相关链接:http://www.reuters.com/article/2012/06/18/us-fda-sanofi-idUSBRE85H0XK20120618 

 

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