FDA approves Gattex for patients with short bowel syndrome

The FDA has approved the use of Gattex to treat short bowel syndrome in adult patients, according to a press release.

Gattex (teduglutide, NPS Pharmaceuticals) is administered intravenously once a day, and is intended for use in patients with short bowel syndrome (SBS) who receive parenteral nutrition. The drug improves the absorption of nutrients and fluids by the small intestine, according to the release.

“Today’s approval expands the available treatment options for patients with this life-threatening condition,” Victoria Kusiak, MD, deputy director of the FDA Center for Drug Evaluation and Research Office of Drug Evaluation III, said in the release. “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.”

According to the release, Gattex may increase the risk for developing intestinal polyps and cancer, as well as intestinal obstructions and gallbladder, biliary tract and pancreatic diseases. The approval includes a risk evaluation and mitigation strategy, which consists of training for prescribers and a communication plan. The FDA also has required a postmarket study of Gattex recipients, including a follow-up period of more than 10 years to continue to evaluate the risk for colorectal cancer and other illnesses associated with the drug.

Common side effects observed during clinical trials included abdominal pain, nausea, headaches, upper respiratory tract infection, abdominal distension and pain at the injection site.

The approval follows a vote in October by the FDA’s Gastrointestinal Drugs Advisory Committee, during which members unanimously agreed that the benefits offered by Gattex outweigh potential risks in this patient population.