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Published on 1 June 2007

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Swiss regulators urge Zelmac withdrawal

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Swiss regulators have followed the lead of their counterparts in the USA and called for Novartis’s irritable bowel syndrome drug Zelmac® (tegaserod) to be withdrawn from the market.

Regulator Swissmedic has refused to extend the licence for Zelmac as a treatment for IBS in women, saying “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, Swissmedic issued new recommendations but said “after careful analysis of the complete data, the risk-benefit ratio for Zelmac now appears unfavourable”.

The Swiss move comes a few months after the FDA asked Novartis to suspend marketing of the drug in the USA, where it is known as Zelnorm, 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 with one case in 7,031 placebo-treated patients.

At the time, Novartis Pharma development chief James Shannon said that while the company had complied with the FDA request, “we continue to believe 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 $561m, with $488m 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 Committee for Medicinal Products for Human Use rejected the application for a second time.

PharmaTimes 1/6/2007

 



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