(By Balaseshan) NPS Pharmaceuticals Inc. (NASDAQ:NPSP) said it has received a notice from the U.S. regulatory authorities that its new experimental bowel drug Gattex will be discussed at advisory committee meeting.
The U.S. Food and Drug Administration (FDA) has notified the company that its new drug aplication (NDA) for Gattex (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for October 16. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is December 30.
Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in normal intestinal function and fluid and nutrient absorption. The proposed indication for Gattex is the treatment of adult patients with short bowel syndrome.
Two phase 3 studies of teduglutide demonstrated a favorable safety profile and significant reductions in mean parenteral nutrition (PN) volume from baseline to end of treatment. In addition some patients were able to be weaned off PN and continue their life without parenteral support.
Gattex has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).
Short bowel syndrome (SBS) is a highly disabling condition that can impair a patient's quality of life and lead to serious life-threatening complications. SBS typically arises after extensive resection of the bowel due to Crohn's disease, ischemia or other conditions.
SBS patients often suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to the reduced intestinal capacity to absorb nutrients, water, and electrolytes. The usual treatment for short bowel syndrome is nutritional support, including PN and/or intravenous (IV) fluids to supplement and stabilize nutritional needs.
NPSP is trading up 3.29% at $7.99 on Tuesday. The stock has been trading between $4.35 and $9.28 for the past 52 weeks.