NPS Pharmaceuticals Reports Data On Gattex Study

NPS Pharmaceuticals

, a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported data related to the seven patients who achieved complete independence from parenteral nutrition (PN) and/or intravenous fluids (IV) while on long-term Gattex® (teduglutide) therapy in STEPS 2, a 24-month, open-label study in adult short bowel syndrome (SBS). The data suggest that patients achieving independence from PN/IV tend to have colon in continuity and lower baseline PN/IV needs than typical patients studied, as all seven patients had baseline PN/IV requirements of less than 13 liters a week. A poster (P1267) titled “Long-Term Therapy With Teduglutide: Characteristics of Patients With Intestinal Failure Associated With Short Bowel Syndrome Who Achieved Complete Independence From Parenteral Nutrition and/or Intravenous Fluid Support” was presented by lead study investigator Ken Fujioka, MD and colleagues at the American College of Gastroenterology Annual Scientific Meeting in Las Vegas, NV. “Patients with short bowel syndrome face numerous medical risks and lifestyle challenges,” said Ken Fujioka, MD, Nutrition and Metabolic Research Center, Scripps Clinic, Del Mar. “They are often tethered to a PN/IV line, have to make frequent trips to the bathroom, suffer from disrupted sleep, and face serious complications including infections, blood clots, or liver damage. The fact that long-term treatment with Gattex has shown to help reduce PN/IV volume or even completely eliminate the need for it is exciting for patients and physicians. Gattex has the potential to be a truly life-changing treatment for adult short bowel syndrome.” Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in normal intestinal function and fluid and nutrient absorption. A New Drug Application (NDA) for Gattex is being reviewed by the U.S. Food and Drug Administration (FDA). On October 16, 2012, the FDA's Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex® (teduglutide) for adults with short bowel syndrome (SBS). The committee's recommendation will be considered by the FDA in its review of the company's NDA. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is December 30, 2012.