Novartis' irritable bowel syndrome (IBS) treatment Zelmac® approved in Switzerland
Novartis announced today that the Swiss Health Authority, the Intercantonal Office for the Control of Medicines (IKS), has granted marketing approval for Zelmac® (tegaserod). Zelmac is the first medication clinically proven to provide a symptomatic treatment for women with abdominal pain and constipation associated with irritable bowel syndrome (IBS). Zelmac will be available in Switzerland within the next few days.
A number of other countries follow the approval of the IKS including several Asia Pacific and Latin American countries, where the drug will soon be launched. Zelmac was recently launched in the Czech Republic, Mexico, Venezuela and Columbia and has gained approvals elsewhere. Novartis is working with the USA Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other regulatory authorities in order to help bring the benefits of this important new therapy to patients in need.
"The approval of Zelmac in Switzerland is a crucial step in our ongoing efforts to launch Zelmac globally. As we continue to negotiate with other regulatory bodies, we will leverage this approval as evidence of the safety and efficacy of Zelmac for IBS patients." said Thomas Ebeling, CEO, Novartis Pharma AG.
Until now, there was no single effective therapy available in Switzerland to treat multiple symptoms of IBS, a chronic, life-altering disorder that can have a significant impact on daily functioning and overall well-being.
In clinical trials involving more than 4,500 patients, two-thirds of patients treated with Zelmac experienced overall symptom relief, including improvements in abdominal pain/discomfort, bloating and constipation1 The majority had relief within one week.2 The drug was well tolerated with an adverse event profile similar to that of placebo, with the exception of headache and diarrhea, which in most cases was mild and transient.3,4 Discontinuations based on adverse events were 6.4 % for the Zelmac treated group compared with 4.6 % for the placebo group in the final trial.
References: 1. Mueller-Lissner S, et al. Tegaserod, a 5HT4 partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Aliment Pharmacol Ther 2001;16:1655–66. 2. Integrated summary of efficacy. January 2000. Novartis, data on file. 3. Lefkowitz M, et al. Tegaserod provides relief of symptoms in female patients with irritable bowel syndrome (IBS) suffering from abdominal pain and discomfort, bloating and constipation. (Abstr). Gastroenterology 2001;120:A104. 4. Integrated summary of safety. December 2000. Novartis data on file.
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