BETHESDA, MD 21 Dec 2012—FDA and NPS Pharmaceuticals Inc. on Decmber 21 announced the approval of teduglutide for s.c. injection for the treatment of short bowel syndrome.
Teduglutide, a recombinant analogue of human glucagon-like peptide 2, will be marketed as Gattex. NPS expects the product to be available during the first quarter of 2013.
According to FDA, teduglutide is indicated for the treatment of adults with short bowel syndrome who require parenteral nutrition to live. The drug should be administered once daily to improve intestinal absorption of fluids and nutrients.
The agency based its approval of teduglutide on the drug's ability to reduce by at least 20% the weekly volume of parenteral nutrient solution required by clinical trial participants. According to FDA, 46% of patients attained this goal after 20 weeks of treatment and 63% did so by week 24 of treatment, compared with 6% and 30% of placebo recipients.
NPS stated that some clinical trial participants who were treated with teduglutide were able to discontinue parenteral nutrition.
A risk evaluation and mitigation strategy (REMS) program consisting of a communication plan and training for prescribers has been developed for teduglutide. According to FDA, the REMS program addresses patients' risk for bowel cancer and abnormal polyps, intestinal obstructions, gallbladder disease, biliary tract disease, and pancreatic disease associated with the drug's use.
FDA stated that the most common adverse events reported in clinical studies of teduglutide were abdominal pain, injection-site reactions, nausea, headache, abdominal distension, and upper respiratory tract infection.
Labeling for teduglutide was not available at presstime.