【drug-news】雅培的减肥药西布曲明前景不明朗
发布于 2010-09-16 · 浏览 1467 · IP 北京北京
这个帖子发布于 14 年零 231 天前，其中的信息可能已发生改变或有所发展。
FDA Advisory Panel Renders Split Decision on Abbott’s Meridia
To those hoping for a clear-as-a-bell signal from today’s FDA advisory committee meeting on Abbott’s weight-loss drug Meridia: sorry.
The committee was split down the middle, with eight members voting to pull the drug and eight to keep it on the market – either with a more prominent boxed warning about potential cardiovascular problems or new restrictions on distribution. Here’s the Dow Jones Newswires story on the committee meeting and vote.
And now — as happened when the panel split its vote on GlaxoSmithKline’s diabetes drug Avandia — it’s time for the tea leaf reading to commence! What will the agency do with this advice? Will it matter that no one voted to keep the drug on the market with its current label? Or that of the eight voting to keep it on the market, six said it should be only with tougher warnings and restricted distribution?
Abbott said in a statement that it proposed a “comprehensive” risk management strategy for use of the drug and will consult with the FDA. “We continue to believe that there are appropriate and identifiable patients that derive benefit” from Meridia, said Eugene Sun, the company’s vice president of global pharmaceutical development.
Making sure those appropriate patients are distinct from the inappropriate ones seems to be key, wrote analysts from Concept Capital in a research note. They said that investors looking for clues to the committee’s reception tomorrow of Arena’s experimental diet drug lorcaserin should note today’s “emphasis on restricted distribution and viable strategies to limit use to an appropriate patient population.”
That’s the rub with weight-loss drugs: while obese patients stand to derive a benefit big enough to override some potential risks, the risk-benefit ratio is much different for someone who takes the drug to lose that last pesky 10 pounds.
The committee voted against recommending Vivus’s Qnexa, another experimental weight-loss drug, in July. Another drug, Orexigen’s Contrave, will have its day before the panel late this year.
http://blogs.wsj.com/health/2010/09/15/fda-advisory-panel-renders-split-decision-on-abbotts-meridia/
To those hoping for a clear-as-a-bell signal from today’s FDA advisory committee meeting on Abbott’s weight-loss drug Meridia: sorry.
The committee was split down the middle, with eight members voting to pull the drug and eight to keep it on the market – either with a more prominent boxed warning about potential cardiovascular problems or new restrictions on distribution. Here’s the Dow Jones Newswires story on the committee meeting and vote.
And now — as happened when the panel split its vote on GlaxoSmithKline’s diabetes drug Avandia — it’s time for the tea leaf reading to commence! What will the agency do with this advice? Will it matter that no one voted to keep the drug on the market with its current label? Or that of the eight voting to keep it on the market, six said it should be only with tougher warnings and restricted distribution?
Abbott said in a statement that it proposed a “comprehensive” risk management strategy for use of the drug and will consult with the FDA. “We continue to believe that there are appropriate and identifiable patients that derive benefit” from Meridia, said Eugene Sun, the company’s vice president of global pharmaceutical development.
Making sure those appropriate patients are distinct from the inappropriate ones seems to be key, wrote analysts from Concept Capital in a research note. They said that investors looking for clues to the committee’s reception tomorrow of Arena’s experimental diet drug lorcaserin should note today’s “emphasis on restricted distribution and viable strategies to limit use to an appropriate patient population.”
That’s the rub with weight-loss drugs: while obese patients stand to derive a benefit big enough to override some potential risks, the risk-benefit ratio is much different for someone who takes the drug to lose that last pesky 10 pounds.
The committee voted against recommending Vivus’s Qnexa, another experimental weight-loss drug, in July. Another drug, Orexigen’s Contrave, will have its day before the panel late this year.
http://blogs.wsj.com/health/2010/09/15/fda-advisory-panel-renders-split-decision-on-abbotts-meridia/
最后编辑于 2022-10-09 · 浏览 1467
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