Teduglutide regulatory update

FDA approved Gattex teduglutide from NPS 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. ...