The Food and Drug Administration on Dec. 21 approved teduglutide, to be marketed under the trade name Gattex, to treat adults with short bowel syndrome (SBS) who need parenteral nutrition.
Teduglutide, a recombinant analogue of human glucagon-like peptide-2 (GLP-2), was unanimously recommended for approval by an FDA advisory panel in October. It is a once-daily subcutaneous injection that helps improve intestinal absorption of fluids and nutrients, reducing the frequency and volume of parenteral nutrition.
"Considering Gattex has been shown to significantly reduce or in some cases even eliminate the requirement for parenteral support, it may become a cornerstone therapy in the management of short bowel syndrome." Dr. Ken Fujioka of the Nutrition and Metabolic Research Center, Scripps Clinic, Del Mar, Calif., said in a statement issued by Gattex’s maker, NPA Pharmaceuticals.
It is the third drug to be approved by the FDA for SBS patients who are dependent on parenteral nutrition. Somatropin (Zorbtive) was approved in 2003 and glutamine (Nutrestore) in 2004.
"Today’s approval expands the available treatment options for patients with this life-threatening condition," Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA Center for Drug Evaluation and Research, said in a statement. "Because Gattex may cause other serious health conditions, it is critical that patients and health care professionals understand the drug’s potential and known safety risks."
Teduglutide therapy increases the risk of developing cancer and polyps in the intestine, obstructions in the intestine, gallbladder disease, biliary tract disease, and pancreatic disease. The drug will have a Risk Evaluation and Mitigation Strategy, consisting of a communication plan and training for prescribers, according to the FDA.
Pivotal data on the drug were published in September in Gastroenterology (Gastroenterology 2012 Sept. 13 [doi:10.1053/j.gastro.2012.09.007]).
