Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Medicines Evaluation Agency has again recommended against approving Novartis' Zelnorm for the treatment of women suffering from irritable bowel syndrome with constipation.
Subscribe to our email newsletter
The decision follows 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,” said Dr James Shannon, head of Global Pharma Development at Novartis Pharma AG. “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, Zelnorm has been studied in more than seven randomized, placebo-controlled clinical trials, including more than 14,000 patients from North and South America, Europe, Asia Pacific and South Africa.
This opinion does not have any impact on the current labeling of Zelnorm for the treatment of IBS in those countries where Zelnorm has already been approved.