NPS Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for Gattex (teduglutide) for the treatment of short bowel syndrome (SBS) in adults. The information in the NDA is derived from 14 completed and one ongoing clinical study. Of the 566 subjects treated with teduglutide, 173 subjects were treated in the SBS efficacy and safety studies.Also, the initial NDA included data from 75 SBS subjects who had at least 12 months of exposure to GATTEX.
Gattex is a recombinant analog of human glucagon-like peptide 2, a peptide involved in gastrointestinal regeneration and repair.
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