NPS Pharma's (NPSP) NDA for GATTEX Accepted by FDA
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NPS Pharmaceuticals, Inc. (Nasdaq: NPSP), announced the U.S. Food and Drug Administration (FDA) has accepted and filed for review the company’s New Drug Application (NDA) for GATTEX (teduglutide) for the treatment of adults with short bowel syndrome or SBS. SBS 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 NDA is the FDA’s determination that the application is sufficiently complete to permit a substantive review.
Under the Prescription Drug User Fee Act (PDUFA), the FDA will notify NPS of its action date, the date FDA commits to providing a decision on the NDA, within the Filing Review Notification, also referred to as the Day 74 letter.
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. The initial NDA included data from 75 SBS subjects who had at least 12 months of exposure to GATTEX.
Under the Prescription Drug User Fee Act (PDUFA), the FDA will notify NPS of its action date, the date FDA commits to providing a decision on the NDA, within the Filing Review Notification, also referred to as the Day 74 letter.
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. The initial NDA included data from 75 SBS subjects who had at least 12 months of exposure to GATTEX.
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