Company is presenting extension study data, and submitting sNDA for expanded label to include it. Not sure what that means in scrips, but can't hurt:
>>NPS Pharmaceuticals, Inc. ( NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today reported that results from the company’s STEPS 2 study of GATTEX® (teduglutide) in patients with Short Bowel Syndrome (SBS) were accepted for presentation at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in San Diego, California, October 11-16, 2013. STEPS 2 was a two-year open-label extension study that involved 88 adult SBS patients with short bowel syndrome. The abstract entitled, “Long-term Safety and Efficacy of Teduglutide for the Treatment of Intestinal Failure Associated with Short Bowel Syndrome: Final Results of the Steps-2 Study, a 2-year, Multicenter, Open-label Clinical Trial” by Schwartz et al. is also being recognized as an ACG Presidential Poster Award recipient. The ACG Educational Affairs Committee identifies the most highly ranked abstracts selected for the poster sessions in each category and acknowledges their achievement with this award. The company also reported that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Gattex, revising the product label to include long-term data from STEPS 2.
“The data from STEPS 2 show the sustained effects of Gattex, as evidenced by parenteral support volume reduction, days off parenteral support or for some patients complete independence from parenteral support,” said Roger Garceau, MD, FAAP, executive vice president and chief medical officer of NPS Pharmaceuticals. “We’re especially pleased that 13 of the 88 patients in the study fall into the latter category, having been completely weaned off parenteral support while on Gattex. We look forward to the FDA’s response to our sNDA.”<<
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Cheers, Tuck |
