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Orexigen减肥药Contrave 如愿以偿获得FDA批准

来源:生物谷 2014-09-11 13:42

2014年9月11日讯 /生物谷BIOON/ --Orexigen公司最近如愿以偿地收获了FDA对其减肥药物Contrave的祝福,这代表该公司完成了一场历时三年的逆袭!这同时也意味着Orexigen公司比其竞争对手,著名生物技术公司诺和诺德提前一步将自家减肥药产品推向市场。

而此时,诺和诺德公司的减肥药物正处于临床晚期研究阶段,等待FDA的审核。志得意满的Orexigen公司CEO Michael Narachi也对Contrave的未来表示乐观。时间倒退到三年前,2011年,Orexigen公司希望开发一种新型减肥药物以帮助肥胖症患者更好降低体重,然而FDA等相关医药管理机构对这一产品的安全性存有疑虑并要求公司提交进一步详细研究数据以证明其安全性。为此Orexigen公司在随后的三年组织了有超过10000名患者参与的临床研究以证明其安全性,并最终俘获FDA"芳心"。

这一切看起来都很像屌丝逆袭的励志故事,但是不要高兴得太早,在生物医药领域,药物获得上市批准仅仅是万里长征的第一步。FDA打开绿灯并不意味着消费者也会买账。举例来说,Arena (Belviq)和Vivus (Qsymia)是在过去几年中最先获得上市批准的新型减肥药物,然而根据其上市几年的业绩来看颇有叫好不叫座之嫌。因此,Orexigen公司能否笑到最后还有待市场反应的检验。





More than three long years after Orexigen was turned back at the FDA and forced to do a costly late-stage safety study of its weight drug Contrave, the agency has come back and given its seal of marketing approval to the drug. The obesity treatment will now weigh in against two struggling therapies that got a head start on cracking the tough market, but it may be only a step ahead of a hungry Novo Nordisk, which is in the final stages of seeking an approval for its own heavyweight contender for the crown of bestselling obesity drug.

"Obesity continues to be a major public health concern," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research. "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition."

Orexigen CEO Michael Narachi has been supremely confident that once he got his hands on an approval, major sales success could be only one step behind. His trump card: A big group of sales reps at Takeda, which is partnered on the therapy and plans to roll it out in style.

Arena (Belviq) and Vivus (Qsymia) won approvals for the first new weight-loss pills in more than a decade back in 2012, but each has struggled to rack up significant sales.

Orexigen all but threw in the towel back in 2011, when the agency insisted on a new late-stage study to nail down clear evidence of its safety. But the biotech eventually decided to come up with the $100 million needed for the additional cardiovascular trial. An interim analysis last fall on the 10,000 patients recruited for the study confirmed what the biotech was looking for, setting the stage for a resubmission.

The drug is approved for use in adults with a body mass index of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia), the FDA noted.

A history of safety issues involving weight drugs tied to trial data reflecting only marginal weight loss among patients has made it hard for the early entries to gain substantial coverage from payers in the U.S. And the FDA's approval comes with significant strings. Orexigen is being required to carry out a followup outcomes trial on cardiovascular risks, two pediatric studies and more trials on cardiac conditions, renal and hepatic impairment and drug-drug interactions. The drug is also tied to higher blood pressure rates and, because it includes bupropion, "has a boxed warning to alert health care professionals and patients to the increased risk of suicidal thoughts and behaviors associated with antidepressant drugs."

Tomorrow Novo Nordisk will face a panel of outside agency experts who will review its application of liraglutide 3 mg, a higher dose of a GLP-1 drug that is approved as Victoza for diabetes and represents a major effort on the Danish pharma company top tackle one of the chief causes of diabetes.


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