NPS Pharmaceuticals Inc. (NPSP) announced Tuesday that the U.S. Food and Drug Administration's or FDA Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex or teduglutide for adults with short bowel syndrome or SBS. The committee's recommendation will be considered by the FDA in its review of the company's New Drug Application or NDA for Gattex. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is December 30, 2012.
NPS also reported that five additional patients have successfully achieved independence from parenteral nutrition or PN and intravenous (IV) fluids while on long-term Gattex (teduglutide) therapy in STEPS 2, a 24-month open-label study in adult SBS. To date, 12 patients or 14 percent have achieved independence from PN/IV fluids while on Gattex therapy in the ongoing STEPS 2 study.
SBS is a serious, complex disorder in which the body is unable to absorb enough nutrients and fluids through the gastrointestinal track to sustain life. SBS is typically treated with PN/IV fluids that do not treat the underlying disorder, which is the body's inability to absorb nutrients and fluids.
Gattex (teduglutide) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. It has been developed to reduce dependence on parenteral nutrition (PN) in adult patients with short bowel syndrome.
The most common treatment-emergent adverse events with Gattex in the placebo-controlled studies that occurred at a higher frequency with Gattex were abdominal pain, upper respiratory tract infections, nausea, injection site reactions, abdominal distension, headaches, and gastrointestinal stoma complications.
Gattex said it has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and the FDA.
by RTT Staff Writer
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