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Novartis Pharmaceuticals IBS drug loses backing

Date published: 16/12/2005

Novartis irritable bowel syndrome (IBS) drug Zelnorm has failed to get backing from European regulators. Although the drug is already on sale in the US and 55 other countries, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) took a negative opinion, following a review that commenced in October last year.

However, Novartis has stated it will appeal the decision on Zelnorm (tegaserod), which is designed for the treatment of women with IBS with constipation (IBS-C). James Shannon, Novartis head of global pharma development, said: "Although we are disappointed with the CHMP opinion, we are confident in the clinical profile and benefits of Zelnorm. This product has been rigorously studied in more than seven placebo-controlled trials involving over 14,000 patients worldwide.

The extensive clinical program and its use in patients in over 30 countries to date have clearly demonstrated the clinical benefits, efficacy and safety of Zelnorm."

Last year worldwide sales of Zelnorm were at $299 million, but the safety of the product was highlighted in the US when extra information had to be added to packs warning about diarrhoea and reduced blood flow to the intestines.

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