NDA Submitted for Gattex for Adult Short Bowel Syndrome
NPS Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the FDA 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 total subjects treated with teduglutide, 173 subjects were treated in the SBS efficacy and safety studies. Seventy-five SBS subjects have >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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