FDA committee to review NPS’ Gattex NDA in October

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its New Drug Application (NDA) for Gattex® (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for October 16, 2012. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is December 30, 2012.

Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in normal intestinal function and fluid and nutrient absorption. The proposed indication for Gattex is the treatment of adult patients with short bowel syndrome.

"Short bowel syndrome is a rare and debilitating condition for which a number of patients must currently rely on parenteral nutrition and intravenous fluids to survive, as there are no approved products for long-term treatment," said Francois Nader, MD, President and Chief Executive Officer of NPS Pharmaceuticals. "We look forward to discussing Gattex with the advisory committee and will continue to work closely with the FDA during its review."    

Source:

NPS Pharmaceuticals, Inc.

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