# CHMP recommends against approval of Novartis' Zelnorm for treatment of IBS-C



## Jeffrey Roberts (Apr 15, 1987)

CHMP recommends against approval of Novartis' Zelnorm for treatment of IBS-CSaturday, March 25, 2006 15:00 IST BaselNovartis has received an opinion from the European Medicines Evaluation Agency's review committee (CHMP) recommending against approval of Zelnorm (tegaserod) in for the treatment of women suffering from irritable bowel syndrome with constipation (IBS-C). This advice followed an appeal procedure undertaken by Novartis in December 2005 after the Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission not approve Zelnorm."We are disappointed with this decision that will prevent women in Europe to have access to Zelnorm, which has proven to be clinically meaningful for the treatment of this disease," Dr. James Shannon, Head of Global Pharma Development at Novartis Pharma AG said adding, "The extensive clinical trials program and its use by nearly four million patients in more than 30 countries, including the US, Canada, and Switzerland, clearly demonstrate the clinical benefits, efficacy and safety of Zelnorm."According to the company release, this opinion does not have any impact on the current labelling of Zelnorm for the treatment of IBS in those countries where Zelnorm has already been approved. Zelnorm is approved for the treatment of IBS-C in more than 56 countries, including Australia, Switzerland, Canada, the United States, Mexico, China and Brazil. Zelnorm is also approved for the treatment of chronic constipation in more than 20 countries including the United States, Canada and Mexico. Novartis markets Zelnorm (tegaserod maleate) in the US, Canada, Philippines and South Africa; and under the trademark Zelmac (tegaserod) in Switzerland, Latin America and Asia-Pacific regions.Copyright Â© Saffron Media Pvt. Ltd.http://www.pharmabiz.com/article/detnews.asp?articleid=32546


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## Jeffrey Roberts (Apr 15, 1987)

This is very disappointing news. It's frustrating when politics appears to play a role in denying patients access to a medication which has shown dramatic efficacy for so many individuals.Jeff


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## SpAsMaN* (May 11, 2002)

Unbeleivable!!!These people are absolutly disconnected with the people who suffer.


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## 20336 (Mar 23, 2006)

Would you both (JR & Spasman*) advocate the removal of all regulatory bodies & leave the drug market as a free-for-all amongst the drug companies, with no-one powerful enough to argue the side of the consumer? I simply don't see on what grounds you criticise this as a purely political decision.


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## Tiss (Aug 22, 2000)

That just sickens me. So many of us (MILLIONS) have been helped by Zelnorm. I can lead a much more normal life. I don't get it!


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## jjohnson (Apr 29, 2004)

I agree this is appalling. Zelnorm is a safe drug by any standard of measure. Analysis of large numbers of IBS patients shows that there is probably no association at all with ischemic colitis (as in zero) with this drug. I also believe that earlier concerns about other safety problems were dispelled by later, larger trials. And I would think that the risk of severe diarrhea resulting in hospitalization can be more than managed by exercising a bit of common sense (something this panel evidently thinks patients with this condition are incapable of.)The most exasperating thing is that it is not that they don't understand, but that they refuse to understand. This obtuseness is so egregious that it really must be deliberate. And I'm sure this panel probably thought they were doing the world a big favor by protecting people from the "disease mongering" of the pharmaceutical industry in promoting "fake illnesses." Or else they were parroting the same tired phrases about the purported effectiveness of conventional "therapy" (with nil evidence to back it up by the way.) And let's not leave out the terrible precedent this sets for all future treatments for IBS in the EU. I'm disgusted, utterly disgusted.And no one is suggesting that the FDA and similar institutions be abolished. The evidence for the safety and effectiveness of this drug is overwhelming, and most of the world has agreed. On the other hand I would take exception to the claim that the FDA truly represents "consumers" (i.e. us patients). The drug approval process is not purely scientific and involves all sorts of (often questionable) value judgments. IBS drugs have had a hard time in particular because our condition is deemed to be nothing more than a "minor nuisance." Most people on this board would beg to differ.


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