NPS' Gattex gets FDA approval for SBS

NPS Pharmaceuticals ($NPSP) got a holiday present from the FDA, which on Friday approved its orphan drug Gattex (teduglutide) to treat adults with short bowel syndrome (SBS).

The market is not huge, about 10,000 to 15,000 people in the U.S., but NPS has forecast about $350 million in sales for the drug.

The orphan drug is designed to reduce dependence among SBS patients on long-term intravenous feeding after the removal of a portion of their intestines, a condition which can be triggered by Crohn's disease. The daily injection improves intestinal absorption of fluids and nutrients, the FDA said.

While it is the first drug approved for the condition since 2004, it came with caveats. Patients treated with Gattex are at higher risk of developing cancer and abnormal growths (polyps) in the intestine, among other concerns. The agency is requiring a Risk Evaluation and Mitigation Strategy, which it says will consist of a communication plan and training for prescribers.

- here's the FDA announcement