NPS Pharmaceuticals Inc. (NPSP) Tuesday said the U.S. Food and Drug Administration has accepted and filed for review the company's New Drug Application for GATTEX for the treatment of adults with short bowel syndrome.
Short bowel syndrome is a rare disorder characterized by inadequate absorption of fluids and nutrients in people who have had a significant portion of their small intestine surgically removed due to disease or injury.
GATTEX is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in gastrointestinal regeneration and repair. The acceptance of the GATTEX New Drug Application is the FDA's determination that the application is sufficiently complete to permit a substantive review.
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