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| |  FDA Grants Priority Review For Zelmac (Tegaserod) For Irritable Bowel Syndrome EAST HANOVER, NJ -- April 12, 2000 -- Novartis Pharmaceuticals Corporation announced that Zelmac(TM) (tegaserod), an innovative treatment for multiple symptoms of irritable bowel syndrome (IBS), has been designated for priority review by the U.S Food and Drug Administration (FDA). Priority review status is granted by the FDA to products that are considered to be a potential therapeutic advance over existing therapies. Actions taken on drugs given a priority review generally are made within six months. A new drug application (NDA) for Zelmac was submitted to the FDA on February 11 of this year. A regulatory submission was also filed with the European Medicines Evaluation Agency (EMEA) on February 16. "We are extremely pleased that the FDA has designated Zelmac for priority review," said David Epstein, Chief Operating Officer, Novartis Pharmaceuticals Corporation. "This designation supports the great need for and the potential of Zelmac in treating the millions of IBS patients who suffer from abdominal pain and constipation as their main symptoms." IBS is one of the most common gastrointestinal (GI) disorders of function, affecting up to 20 percent of the Western population. It is estimated to be the second most common cause of absenteeism from work in the US, accounting for one in four visits to gastroenterologists, and costing the healthcare system $8 billion each year. IBS is a chronic condition characterized by abdominal pain, bloating and symptoms associated with irregular bowel function, such as constipation, diarrhea or an alternating pattern between the two. To date, no medication has proven to be safe and effective in treating IBS patients who suffer from abdominal pain, constipation and bloating as their main symptoms. Zelmac belongs to a new chemical class of compounds which selectively target and act on 5-HT4 receptors present throughout the GI tract. These serotonin receptors are believed to play a key role in pain perception and GI motility. By acting on the 5-HT4 receptor pathway, Zelmac reduces abdominal pain and may normalize altered GI function in IBS patients who suffer from abdominal pain, constipation and bloating as their predominant symptoms. Novartis is currently assessing Zelmac as a potential treatment for other GI disorders of function such as gastrointestinal reflux disease (GERD) and functional dyspepsia. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including gastroenterology, central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The Company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of USD 21.7 billion and invested more than USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000. Related Links: Zelmac (tegaserod) and Novartis Pharmaceuticals Corporation.
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