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【编译】万络拉开重返市场的序幕 SCRIP 2005-02-2
美国FDA专家组通过讨论同意已撤市的默克（Merck & Co）公司产品万络（Vioxx，rofecoxib）在加入黑框警示后重返市场。
虽与会专家一致认为万络对心血管有毒副作用，但随着该品去年九月的召回，越来越多的数据证明所有的cox-2抑制剂都存在心血管安全性方面的问题，且万络具有对胃肠的有利作用、对青少年风湿性关节炎的独特疗效和适用于对磺胺类药物过敏的患者等优点，专家组认为万络无需退出市场。然而，在该品重返市场前，FDA还须对其安全性进行再次确认。
无可置疑，万洛的副作用将对默克公司的发展前景蒙上阴影，但此次FDA专家组的讨论结果增加了默克公司应对法院自辩的筹码。
城门失火，殃及池鱼。默克公司万络的事发直接影响到了辉瑞（Pfizer）公司的同类产品希乐葆（Celebrex，celebrex）。上周欧洲药品监管机构发表声明，APC试验结果发出服用希乐葆将引发心血管疾病的信号，对辉瑞带来沉重打击。尽管鲜有证据证明200mg剂量会对心血管产生影响。由于希乐葆不具备万络对胃肠有利的条件，故此次听证会对辉瑞公司的影响可能更大。辉瑞将由此遭受希乐葆对DTC广告的一切禁令，尽管FDA承认此禁令较难运行。
对于默克公司而言，失去DTC广告的宣传，增添了杀回市场的万络重塑在消费者中信誉的难度。但当务之急是在产品说明书上加上可能引发心血管危险的黑框警示。
原文：http://www.pharmadl.com.cn/database/resultdetail.jsp?id=25154&databaseName=scrip
Troubled Merck & Co can only gain from coxib decision
SCRIP 2005-02-23
With Vioxx (rofecoxib) already withdrawn, Merck & Co has everything to gain from re-launching the product, even with a restrictive black box warning, now that an FDA panel meeting has paved the way for its return.
But with the panel’s confirmation of a class effect of cardiovascular side-effects, the repercussions of the meeting could be worse for Pfizer. Celebrex (celecoxib) can no longer take refuge in its cardiovascular profile, even though there is less evidence of a cardiovascular effect with the 200mg dose, and it has never had the gastrointestinal benefits of Vioxx that the COX-2 class was designed to deliver.
The class effect verdict, which echoed that of European regulators last week, is a particular blow to Celebrex as only the APC trial gave definitive evidence of a cardiovascular signal. But a confirmed class effect became more and more likely as data on cardiovascular risk across the class snowballed following the withdrawal of Vioxx last September.
It makes sense for Merck to ensure that Vioxx is not left out of the coxib market because all the products are now subject to caveats about their cardiovascular safety. The company needs to capitalise on Vioxx’s demonstrated gastrointestinal benefit and its unique position as a treatment for juvenile rheumatoid arthritis and an alternative for patients allergic to sulphonamide.
Vioxx could gain if the other coxibs are dragged down to its level in terms of cardiovascular safety. While Merck now agrees there is a class effect, in the days after it withdrew Vioxx it made sense for it to believe the bulk of evidence was against a class effect, especially as it had the follow-up product, Arcoxia (etoricoxib), in the pipeline. However, it remains to be seen what reassurances, if any, the FDA will need before Vioxx can return to the market.
All the companies involved in the COX-2 inhibitor debate need to devote time to understanding the basic science behind the cardiovascular side-effects. This could well help them develop next-generation analgesics with the dual gastrointestinal and cardiovascular safety that has eluded them so far.
And while the possible liability for Vioxx-related side-effects has clouded Merck’s future prospects, the outcome of the FDA panel meeting could help the company defend itself against the claims in court.
Pfizer would suffer from any possible ban on direct-to-consumer advertising, although the FDA admitted this might be difficult to enforce. It will be hard for Merck to rally consumer confidence in a re-launched Vioxx without DTC advertising, but in the circumstances this may not be something the company wants to push for.
Patients and physicians may even turn away from the whole class and stick with older non-steroidal anti-inflammatories with better understood cardiovascular profiles and GI bleeding problems that can be managed as they occur.
Unlike Merck, which now has options where previously the outlook was bleak, Pfizer can only lose sales of its coxib franchise as it feels the squeeze of a black box warning. [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-03-04 01:26
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