NPS Pharmaceuticals (NPSP) Completes GATTEX NDA Submission to FDA
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NPS Pharmaceuticals, Inc. (Nasdaq: NPSP), has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for GATTEX (teduglutide).
NPS has also asked the FDA to designate the application for Priority Review, which is given to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. GATTEX is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in gastrointestinal regeneration and repair, which NPS has been developing for the treatment of adults with short bowel syndrome or SBS, a highly disabling and potentially life-threatening chronic disorder.
The company’s SBS clinical development program represents the largest and most comprehensive to date. The information in the NDA is derived from 14 completed and one ongoing clinical study. A total of 566 subjects have been treated with teduglutide. Of the 566 subjects treated with teduglutide, 299 subjects were treated in the clinical pharmacology studies, 94 subjects in Crohn’s Disease studies, and 173 subjects in the SBS efficacy and safety studies. Seventy-five SBS subjects have more than 12 months of exposure to GATTEX.
NPS has also asked the FDA to designate the application for Priority Review, which is given to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. GATTEX is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in gastrointestinal regeneration and repair, which NPS has been developing for the treatment of adults with short bowel syndrome or SBS, a highly disabling and potentially life-threatening chronic disorder.
The company’s SBS clinical development program represents the largest and most comprehensive to date. The information in the NDA is derived from 14 completed and one ongoing clinical study. A total of 566 subjects have been treated with teduglutide. Of the 566 subjects treated with teduglutide, 299 subjects were treated in the clinical pharmacology studies, 94 subjects in Crohn’s Disease studies, and 173 subjects in the SBS efficacy and safety studies. Seventy-five SBS subjects have more than 12 months of exposure to GATTEX.
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