Novartis 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.