FDA approves Gattex (NPS Pharma) for adult patients with Short Bowel Syndrome

The FDA has approved Gattex (teduglutide), from NPS Pharma, for subcutaneous use for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The drug was approved in the EU in September 2012 as Revestine. Gattex will be available in the first quarter of 2013.

The FDA's approval of Gattex was based on an international, 24-week, double-blind, placebo-controlled, pivotal Phase III trial, known as STEPS. The primary endpoint of STEPS was defined as a 20 percent or greater PN/IV volume reduction demonstrated at week 20 and sustained at week 24. The study's secondary endpoints included reductions in PN/IV volume and additional days off therapy. After 24 weeks of treatment, 54 percent of Gattex-treated patients were able to reduce the number of infusion days per week by one or more days, compared to 23 percent of those treated with placebo.