FDA Panel Backs NPS Pharmaceuticals, Inc.'s Drug for Short Bowel Syndrome
Published: Oct 17, 2012
U.S. drug advisers on Tuesday backed a drug to treat a rare and serious bowel disorder for which there is no long-term treatment available in the United States. A panel of outside advisers to the U.S. Food and Drug Administration agreed that NPS Pharmaceuticals Inc had demonstrated that the drug is safe and improves absorption of fluid and nutrients in the intestines of adults with short bowel syndrome. The 12-member panel voted unanimously in the drug's favor. The FDA usually follows the advice of expert panels. The drug, called teduglutide, is one of NPS Pharmaceuticals' lead drugs. Short bowel syndrome - a so-called orphan disease, meaning it affects a small number of people - is a condition in which the body is unable to absorb enough nutrients and/or fluids through the gastrointestinal tract and that forces patients to rely chronically on intravenous feeding. The disease may result from the surgical removal of all or part of the intestine, or the patient may have been born with short intestines. An estimated 10,000 to 15,000 American adults have short bowel syndrome severe enough to require intravenous feeding.