PDUFA: Sept 30 — NPS Pharmaceuticals

NPS Pharmaceuticals expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of GATTEX, being developed for the treatment of adult short bowel syndrome.

NPS Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing small molecule drugs and recombinant proteins. Its product candidates, which are in various stages of clinical and preclinical development, are primarily for the treatment of bone and mineral disorders, gastrointestinal disorders and central nervous system disorders.

GATTEX is the trade name for teduglutide, a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. NPS has has demonstrated in clinical studies that GATTEX significantly reduced parenteral nutrition and intravenous fluid volumes in adult subjects with SBS, with no significant adverse events.

On September 4, the company (jointly with Takeda Pharmaceuticals) announced market authorization in Europe for the drug — marketed as Revestive internationally — as a once-daily treatment for adult patients with short bowel syndrome.

There is an absence of registry data in the United States, however it is estimated over 4 million people in Europe suffer from complications related to adult short bowel syndrome. Several different processes — congenital and acquired — may result in the development of short bowel syndrome, including: congenital intestinal atresia; or massive enterectomy conditions.

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