NPS Pharmaceuticals announced that the FDA has approved Gattex (teduglutide [rDNA origin]) for Injection, as subcutaneous use for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support.
The approval of Gattex was based on an international, 24-week, double-blind, placebo-controlled, pivotal Phase 3 trial, known as STEPS. The primary endpoint was defined as a >20% PN/IV volume reduction demonstrated at Week 20 and sustained at Week 24. Results showed significant reductions in parenteral (PN) and IV volume and infusion days per week were achieved from pre-treatment baseline. In addition, some patients achieved independence from PN/IV support.
Teduglutide is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
Gattex will be available in the first quarter of 2013.
For more information call (855) 542-8839 or visit www.npsp.com/Gattex.