Published on August 22, 2012 at 1:00 AM
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.