FDA Approves Updated Labeling for Gattex® for Injection to Include Long-Term Data
NPS Pharmaceuticals, Inc., a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Gattex® (teduglutide [rDNA origin]) for injection to include long-term data from the STEPS 2 study of adult patients with Short Bowel Syndrome (SBS). The data demonstrate that patients who continued Gattex treatment beyond two years achieved clinically meaningful reductions in parenteral support requirements, including volume and days off, with 13 out of 88 patients across all groups achieving complete independence.
In the U.S., Gattex is indicated for the treatment of adult patients with SBS who are dependent on parenteral support.
“We are pleased that the FDA has approved updated labeling for Gattex, as it provides important information for healthcare professionals and patients about long-term use of Gattex therapy,” said Roger Garceau, MD, FAAP, executive vice president and chief medical officer of NPS Pharma. “The STEPS 2 study demonstrated that there was an increased response to treatment over time in all groups receiving Gattex in terms of volume reductions, days off and complete weaning of parenteral support.”