Novartis will appeal an opinion from a European Medicines Agency (EMEA) committee recommending against European approval of Zelnorm (tegaserod) for the treatment of women with irritable bowel syndrome with constipation (IBS-C).
According to the company release, Novartis decided to take this action after the European Committee for Medicinal Products for Human Use (CHMP) recommended the European Commission not approve Zelnorm, which has been approved to date in 56 countries, including the US.
"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 programme and its use in patients in over 30 countries to date have clearly demonstrated the clinical benefits, efficacy and safety of Zelnorm," said James Shannon, head of global pharma development at Novartis Pharma AG.
The clinical programme included the ZENSAA (Zelnorm in Europe, North and South America and Africa) registration trial, which was designed in line with the recommendations from the scientific advice working group of the CHMP.
The ZENSAA results, a trial involving more than 2,600 patients, showed a statistically significant improvement in the efficacy of Zelnorm following initial as well as repeated use in women with IBS-C. Data also showed a favourable safety profile and good tolerability. ZENSAA is the only IBS-C trial designed to assess the efficacy of repeated treatments and is the largest study ever conducted for this condition, added the release.
"IBS-C can be very restricting and has a negative impact for patients, not only on a person's health but on also their ability to work and socialise," said Professor Jan Tack, associate professor and associate head of clinic, department of gastroenterology, University of Leuven, Belgium, who also served as the lead investigator of ZENSAA.
"Based on the size and scope of this trial, the results reinforce what researchers and clinicians have known for years about the clinically meaningful effect of tegaserod for the treatment of IBS-C. Now we have the added benefit with tegaserod to potentially also improve the quality of life for women with IBS-C," stated Tack.
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.