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FDA专家顾问小组建议批准减肥药lorcaserin

来源:环球医学编译    时间:2012年05月14日    点击数:    5星

5月14日消息 - 环球医学据悉,美国政府卫生监管机构顾问于5月10日建议批准销售一种新的减肥处方药,尽管他们为该药的心脏风险担忧,该药有望成为美国十余年来的首个新型减肥处方药。

FDA的一个专家顾问小组以18比4的投票建议批准Arena制药公司的lorcaserin,专家顾问小组得出结论认为该药在长期应用于超重和肥胖人群时的好处大于其潜在的风险。一名小组成员投了弃权票。

“我们将继续与FDA合作完成本次审查,”Arena公司的CEO Jack Lief在一份声明中说。

该公司指出,FDA已经设定了决定是否批准该药物销售的目标日期(6月27日)。该药是为至少出现一种体重相关性健康问题(如高血压)的肥胖或超重人群准备的。

尽管FDA并没有义务遵循顾问小组的意见,不过往往会遵照其建议。

lorcaserin是三种实验性减肥药之一,在FDA于2010年或2011年年初因为严重的潜在副作用将这三种药物全部拒绝后,其开发商一直在进行第二次努力试图获得批准。

在联邦卫生监管部门给予了lorcaserin令人惊讶的良好评价两天后,顾问小组于周二进行了投票表决。2010年,顾问小组的科学家们基于对该药的健康问题的担忧——包括该药的实验动物出现了肿瘤,建议FDA拒绝批准此药。

在此期间,此家位于圣地亚哥的公司再次申请批准,提交额外的数据,希望能影响该机构做出有利的决定。

由FDA的工作人员对所有的研究进行的一项审查于周二发布于网上,审查声明,Arena公司提交的新的分析表明,服用该药的人群罹患肿瘤的风险是“微不足道”的。然而,仍然存有可能增加糖尿病患者高血压风险或损害心脏瓣膜风险的问题,损害心脏瓣膜是一种与一些早期减肥药有关的危及生命的副作用。

今年早些时候,Arena公司的竞争对手Vivus公司的减肥药Qnexa令人惊讶地赢得了FDA专家小组的认可。这一举动燃起了Arena公司和Orexigen Therapeutics公司的希望,Orexigen Therapeutics公司是第三家竞争生产首个进入药店的减肥药物的公司。

但一个月前,Vivus公司表示,FDA已将对Qnexa作出最终裁决的目标日期由4月17日推迟至7月17日。该机构表示,它需要更多的时间来考虑由Vivus公司提交的一份新的药物安全性计划。

虽然患者和医生都渴望对抗肥胖的新选择,但这些药物都不能使患者奇迹般地减轻体重。

研究表明,受试者服用lorcaserin可轻度减重,一年平均减重仅为初始体重的3.1%。超过37%的患者减重超过本身体重的5%或以上,这足以满足FDA的有效性标准。相比之下,Qnexa将体重平均减少了11%,超过83%的患者减重超过本身体重的5%或以上。

在顾问小组投票公布之后,Arena公司说,它已扩大与其合作伙伴卫材公司(一家位于日本的大型制药商)在美国之外的市场营销和供应协议。如果lorcaserin最终被批准,卫材还将掌握该药在北美和南美的大部分地区的独家营销和分销权。(环球医学)

原文:

FDA Advisers Recommend Approval of Weight Loss Drug An anti-HIV combination

Advisers to government health regulators recommended on May 10 that they approve sales of what would be the first new prescription weight-loss drug in the United States in more than a decade, despite concerns over cardiac risks.

A panel of expert advisers to the Food and Drug Administration voted 18-4 to recommend approval of Arena Pharmaceuticals Inc.'s lorcaserin, concluded that its benefits "outweigh the potential risks when used long term" in overweight and obese people. One panel member abstained from voting.

"We will continue to work with the FDA as the agency completes its review," Arena CEO Jack Lief said in a statement.

The company noted that the FDA has set a target date of June 27 for deciding whether to approve sales of the drug. It's intended for people who are obese or for people who are overweight and have at least one weight-related health problem, such as high blood pressure.
The FDA is not bound to follow the advice of its advisory panels, but generally does so.

Lorcaserin is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.

The panel's vote Thursday comes two days after federal health regulators gave a surprisingly favorable assessment of lorcaserin. When the agency turned the drug down in 2010, its scientists raised concerns about health issues including tumors that developed in laboratory animals tested with the drug.

In the interim, the San Diego company again applied for approval, submitting additional data in hopes of swaying the agency to a favorable decision.

A review of all the research studies by FDA staff, posted online Tuesday, stated that new analysis Arena submitted suggests there's only a "negligible risk" of tumors in people taking the drug. However, questions remain about it possibly increasing risk of high blood pressure in diabetics or damaging heart valves, a life-threatening side effect that has been an issue with some earlier weight-loss pills.

Earlier this year, rival Vivus Inc. won a surprising endorsement from an FDA panel for its diet drug, Qnexa. That move raised expectations for both Arena and Orexigen Therapeutics Inc., the third company racing to get the first new diet drug into drugstores.

But a month ago, Vivus said that the FDA had pushed back its target date for a final decision on Qnexa from April 17 until July 17. The agency said it needed more time to consider a new drug safety plan submitted by Vivus.

While patients and doctors are eager for new options to fight obesity, none of these drugs enable patients to magically shed pounds.

Research showed that study subjects taking lorcaserin had modest weight loss, on average losing just 3.1 percent of starting body weight over a year. More than 37 percent of patients lost 5 percent of their weight or more, which is enough to meet FDA standards for effectiveness. By comparison, average weight loss with Qnexa was 11 percent, with more than 83 percent of patients losing 5 percent of their weight or more.

Following announcement of the advisory panel vote, Arena said it had expanded its marketing and supply agreement with partner Eisai Inc., a large drugmaker based in Japan, beyond the United States. If lorcaserin ultimately is approved, Eisai will also handle exclusive marketing and distribution of the drug in most of North and South America.
 

相关链接:http://www.dddmag.com/news/2012/05/fda-advisers-recommend-approval-weight-loss-drug

 

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