8:14AM NPS Pharm reports Gattex Steps 2 study to be presented at american college of gastroenterology meeting; supplemental new drug application submitted for STEPS 2 data (NPSP) 33.49 : Co reported that results from the company's STEPS 2 study of GATTEXin patients with Short Bowel Syndrome 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 to the FDA for Gattex revising the product label to include long-term data from STEPS 2.
Gattex is indicated for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support. Significant reductions in mean PN/IV infusion volume from baseline to end of treatment were seen in the Phase 3 studies of Gattex. In addition, some patients were able to achieve independence from PN/IV support during these trials. The most common side effects of Gattex include stomach area (abdomen) pain or swelling, skin reaction where the injection was given, nausea, headache, cold or flu like symptoms, vomiting, and holding too much fluid in the body.
NPS is preparing to engage in the pricing and reimbursement processes in key European countries with the goal of commercially launching Revestive in Europe in the first half of 2014. Teduglutide has orphan drug designation for the treatment of SBS from the European Medicines Agency and the FDA.
