Swiss regulators are following the lead of their counterparts in the USA and have called for Novartis’ irritable bowel syndrome drug Zelmac to be withdrawn from the market.
Swissmedic has refused to extend the licence for Zelmac (tegaserod) as a treatment for IBS in women, claiming that “the risks are greater than the benefit.” The agency noted that a new analysis of clinical data, which it requested, revealed an increased risk of cardiovascular conditions such as angina pectoris and heart attack when compared to placebo. At the end of March this year, Swissmedic issued new recommendations but “after careful analysis of the complete data, the risk-benefit ratio for Zelmac now appears unfavourable”.
The Swiss move comes a couple of months after the US Food and Drug Administration asked Novartis to suspend US marketing of the drug, known as Zelnorm there, after the firm notified the agency about a retrospective analysis of data from more than 18,000 patients on its clinical trial database. The data showed that events occurred in 13 out of 11,614 patients treated with Zelnorm, compared to one case in 7,031 placebo-treated patients.
At the time, James Shannon, head of development at Novartis Pharma, said that although the company has complied with the FDA's request, "we continue to believe that Zelnorm provides important benefits for appropriate patients." The treatment has been quite a big earner for the firm and sales in 2006 rose 34% to $561 million, with $488 million coming from the USA.
Now with Switzerland withdrawing Zelmac the future looks bleak. The likelihood of a European launch all but vanished a year ago after the EU's Committee for Medicinal Products for Human Use rejected the application for a second time.