Novartis Committed To Making Zelnorm(R) Available For Women With Irritable Bowel Syndrome With Constipation In Europe
Novartis decided to take this action after the European Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission not approve Zelnorm, which has been approved to date in 56 countries, including the US.
"Although we are disappointed with the CHMP opinion, we are confident in the clinical profile and benefits of Zelnorm. This product has been rigorously studied in more than seven placebo-controlled trials involving over 14,000 patients worldwide," said James Shannon, Head of Global Pharma Development at Novartis Pharma AG. "The extensive clinical program and its use in patients in over 30 countries to date have clearly demonstrated the clinical benefits, efficacy and safety of Zelnorm."
The clinical program included the ZENSAA (Zelnorm in Europe, North and South America and Africa) registration trial, which was designed in line with the recommendations from the Scientific Advice Working Group of the CHMP.
The ZENSAA results, a trial involving more than 2,600 patients, showed a statistically significant improvement in the efficacy and tolerability of Zelnorm following initial as well as repeated use in women with IBS-C. Data also showed a favorable safety profile. Final data from this landmark study have been published in the December issue of GUT, a peer review journal published by the British Society of Gastroenterology. ZENSAA is the only IBS-C trial designed to assess the efficacy of repeated treatments and is the largest study ever conducted for this condition .
"IBS-C can be very restricting and has a negative impact for patients, not only on a person's health but on also their ability to work and socialize," said Professor Jan Tack, Associate Professor and Associate Head of Clinic, Department of Gastroenterology, University of Leuven, Belgium, who also served as the lead investigator of ZENSAA. "Based on the size and scope of this trial, the results reinforce what researchers and clinicians have known for years about the clinically meaningful effect of tegaserod for the treatment of IBS-C. Now we have the added benefit with tegaserod to potentially also improve the quality of life for women with IBS-C."
ZENSAA results show benefits of Zelnorm treatments
ZENSAA results demonstrated that repeated treatment with Zelnorm was generally effective and provided relief of multiple IBS-C symptoms. Zelnorm significantly improved several aspects of quality of life as measured by validated scales. Patients in the ZENSAA trial treated with Zelnorm 6 mg twice daily experienced :
-- A significant decrease in abdominal discomfort or pain during the initial treatment and retreatment periods based on stringent efficacy criteria, which was satisfactory relief in at least three of the four weeks in the trial. Zelnorm's treatment benefit over placebo was 9.1% (p
Novartis angajamentul de a face Zelnorm (R) disponibile pentru femeile cu sindromul intestinului iritabil cu constipaþie în Europa - Novartis Committed To Making Zelnorm(R) Available For Women With Irritable Bowel Syndrome With Constipation In Europe - articole medicale engleza - startsanatate