NPS Pharmaceuticals, Inc. (NPSP) Release: FDA Approves Updated Labeling For Gattex® (Teduglutide [RDNA Origin]) For Injection To Include Long-Term Data
6/30/2014 10:35:19 AM
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, 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.
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