FDA to Review Gattex sNDA for Short Bowel Syndrome
NPS Pharmaceuticals announced that the FDA has accepted for review its supplemental New Drug Application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Gattex for injection is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
The company is seeking to add long-term data from STEPS 2, a two-year open-label extension study in which 88 adult patients with SBS dependent on parenteral support received Gattex 0.05 mg/kg/day to the product label.
Previously the FDA granted teduglutide Orphan Drug designation for the treatment of Short Bowel Syndrome.
Gattex is already approved for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support.For more information call (855) 542-8839 or visit Gattex.com.