Novartis to appeal Zelnorm rejection
pharmafile | January 18, 2006 | News story | Sales and Marketing |
Novartis says it will appeal against an EMEA decision not to recommend its irritable bowel syndrome drug Zelnorm.
Zelnorm (tegaserod) has been approved in the US since 2002 for the short-term treatment of women with irritable bowel syndrome with constipation (IBS-C), but its long list of side-effects and limited efficacy means doubts have persisted around the drug.
Despite this, the drug is now approved for IBS-C in 56 countries and for chronic constipation in more than 20 countries, treating conditions with few other medicinal options.
Zelnorm earned $295 million in the first nine months of 2005, with the US accounting for over 80% of sales.
Novartis supported its European application with the ZENSAA (Zelnorm in Europe, North and South America and Africa) study, published in the December issue of Gut. The study involved 2,660 women – 1,191 of whom received repeated treatment – making it the largest study for IBS-C. The study suggested that Zelnorm provides rapid and sustained relief of IBS-C symptoms – including abdominal discomfort or pain – and improves quality of life during first and repeated treatment.
But the EMEA's committee the CHMP has recommended refusing marketing authorisation, expressing concern the trial results would not translate into real benefit in standard healthcare settings. The committee also considered that the data was inconclusive to support repeated treatment and was of the opinion that Zelnorm's benefits are not greater than its risks.
In April 2004, the FDA updated Zelnorm's labelling to include, among other revisions, a warning about the serious consequences that can arise from diarrhoea associated with the drug and precautions about intestinal ischemia, although a causal relationship with the latter remains unproven.
James Shannon, head of global pharma development at Novartis said: "Although we are disappointed with the CHMP opinion, we are confident in the clinical profile and benefits of Zelnorm. 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."
Another treatment for IBS, GlaxoSmithKline's Lotronex was withdrawn from the US market in 2001 because of serious safety concerns, only to be reintroduced a year later with new restrictions to its use.
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