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news.NPS Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Gattex (teduglutide) indicated for Short Bowel Syndrome (SBS) in adults.
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Gattex is a novel, recombinant analog of human glucagon-like peptide 2, which is involved in gastrointestinal regeneration and repair.
The NDA is submitted on the basis of 14 completed and one ongoing clinical study, which demonstrated the efficacy of the drug candidate.
NPS Pharmaceuticals president and CEO Francois Nader said the NDA submission was a major step in the advancement of Gattex development to make an impact on SBS patients.
"Gattex could represent the first FDA-approved therapy indicated for the long-term treatment of this condition, potentially reducing or even eliminating a patient’s dependence on intravenous nutrition and fluid," Nader added.