FDA approves Gattex for SBS

FDA approved Gattex teduglutide from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) to treat adults with short bowel syndrome (SBS) who are dependent on parenteral support. The company said it plans to launch the analog of glucagon-like peptide-2 (GLP-2) in the U.S. in 1Q13 and will disclose details on the drug's pricing early next year. The approval comes with a REMS that includes a communication plan and training for prescribers. NPS is also required to conduct a postmarketing study in SBS patients to evaluate the drug's potential increased risk of causing colorectal cancer and other conditions. ...