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诺和诺德减肥药liraglutide获得FDA专家委员会支持

来源:生物谷 2014-09-12 22:00

2014年9月12日讯 /生物谷BIOON/ --FDA下属专家委员会最近以14票赞成1票反对的绝对多数表示支持诺和诺德开发的减肥药物liraglutide。为诺和诺德最终将其推上市场扫清了又一个障碍。此前liraglutide已经作为糖尿病特效药上市。有分析人士估计,这一药物一旦上市,其销售额或将再增添10亿美元之多。此次FDA的专家委员会主要评估了3mg剂量的liraglutide对肥胖症患者的疗效,根据诺和诺德提供的最近临床三期研究显示,60%的肥胖症患者在服用该药后体重降幅达到5%,有三分之一的患者体重降幅达到了10%以上。

随后FDA的工作人员将最终决定liraglutide能够通过其第二次审批。FDA预计将在2014年10月20日之前做出最后决定。现在看来,诺和诺德得偿所愿的可能性相当大,因为虽然FDA在绝大多数情况下都会慎重考虑专家委员会的意见。

Liraglutide的有效成分与诺和诺德现有糖尿病畅销药物Victoza相同,去年Victoza为诺和诺德带来了21亿美元的进账,比2012年增加了27%。可以预见liraglutide一旦上市,势必促进Victoza销量的又一次飞跃。

不过,预测终究是预测。在许多分析人士看涨liraglutide的同时,减肥药市场却并不像大家想象的那么乐观。2012年Arena和Vivus公司曾联合推出了一种新型减肥药,但是过于强烈的副作用导致该药物上市后反响平平。Liraglutide似乎并未打消FDA在这方面的疑虑,因为这种药物有可能引发患者出现胰腺炎的副作用。另一方面,就在一天之前,诺和诺德公司在减肥药市场强有力的竞争者Orexigen公司开发的减肥药Contrave已经获得了FDA的上市许可。

Liraglutide是一种胰高血糖素样肽-1(GLP-1)类似物,它能够与GLP-1受体结合并促进胰岛素分泌。(生物谷Bioon.com)

相关新闻链接:Orexigen减肥药Contrave 如愿以偿获得FDA批准

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详细英文报道:

Novo Nordisk ($NVO) convinced a group of FDA advisers that its liraglutide, already a blockbuster diabetes treatment, can effectively combat obesity, clearing the way for a second indication that could add $1 billion to its annual sales.

The panel voted 14-1 that Novo's pivotal data support full approval for a 3 mg injection of the drug, which is marketed at lower doses as the diabetes-treating Victoza. The advisory committee ruled that liraglutide's benefits outweigh its risks, pointing to Phase III data in which about 60% of the obese patients reduced their body weight by at least 5%, and nearly one-third of them shed more than 10%.

Now it's up to FDA staff whether to grant liraglutide its second approval, and a final decision is expected by Oct. 20. The agency is not beholden to follow the votes of its advisers, though it commonly does.

If approved for obesity, Novo plans to market its 3 mg shot as Saxenda, and analysts have said the new indication could heap another $1 billion a year onto liraglutide's sales at its peak. Victoza brought in about $2.1 billion for Novo last year, growing 27% over 2012.

But the recent history for weight-loss drugs suggests Saxenda is no sure bet. In 2012, Arena ($ARNA) and Vivus ($VVUS) won FDA nods for new obesity pills with similarly starry-eyed projections, but safety concerns and payer disinterest led to disappointing launches, and both companies have struggled to gain any market traction. On Thursday, Orexigen ($OREX) picked up FDA approval for Contrave, its long-delayed weight-loss treatment, but investors worry that the drug's long list of potential side effects will doom it to the same fate. The biotech's shares have slumped more than 10% since.

And liraglutide is not without its own safety concerns. The FDA has an open file on the drug's relationship to pancreatitis, an issue that led advocacy group Public Citizen to clamor for a ban on U.S. sales. Furthermore, in reviewing its obesity application, FDA advisers pointed to a spike in breast malignancies among female patients taking the drug, saying the injection's role in cancer promotion remains an open question.

Liraglutide works by bolstering the hormone glucagon-like peptide-1, which is naturally released after eating and regulates the body's insulin secretion. The treatment binds to GLP-1 receptors and stimulates the release of glucose-dependent insulin while suppressing the release of glucagon, a hormone that raises blood sugar concentration.

"We are pleased with the clear recommendation from the advisory committee," Novo Chief Science Officer Mads Krogsgaard Thomsen said in a statement. "... Obesity is a serious public health issue in the U.S., and we are committed to making Saxenda a new treatment option for adults with obesity."

 

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