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FDA Committee Recommends Approval of Gattex (Teduglutide) for Short Bowel Syndrome
Final agency decision expected in December (Oct. 16)
At a meeting held on October 16, the FDA’s Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex (teduglutide; NPS Pharmaceuticals) for adults with short bowel syndrome (SBS). The committee’s recommendation will be considered by the FDA in its review of the new drug application (NDA) for Gattex. The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA’s review is December 30, 2012.
SBS is a disabling condition that typically occurs after extensive resection of the bowel because of Crohn's disease, ischemia, or other conditions. Patients with SBS often experience malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to a reduced intestinal capacity to absorb nutrients, water, and electrolytes. The usual treatment of SBS consists of nutritional support, including parenteral nutrition (PN) and/or intravenous (IV) fluids to supplement and stabilize the patient’s nutritional needs.
Although PN can provide nutritional support for SBS patients, it does not improve the body's ability to absorb nutrients. PN is associated with serious complications, such as infections, blood clots, and liver damage, and the risks increase the longer patients are on PN.
Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 — a protein involved in rehabilitation of the intestinal lining. The drug was developed to reduce dependence on PN in adult patients with SBS.
In clinical studies, the treatment-emergent adverse events that occurred more often with Gattex than with placebo were abdominal pain, upper respiratory tract infections, nausea, injection-site reactions, abdominal distension, headaches, and gastrointestinal stoma complications.
Source: NPS Pharmaceuticals, October 16, 2012.