The FDA announced the approval of Gattex (teduglutide) to treat patients and individuals who are suffering from short bowel syndrome (SBS) and need additional nutrition from intravenous feeding (parenteral nutrition).

The approved injection strengthens the intestinal lining and stimulates the absorption of food and nutrients from the tract to the body. The injection is administered once daily to help improve intestinal absorption of fluids and nutrients, reducing the frequency and volume of parenteral nutrition. SBS is a condition that results from the partial or complete surgical removal of the small and/or large intestine. Extensive loss of the small intestine can lead to poor absorption of fluids and nutrients from food needed to sustain life. As a result, patients with SBS often receive parenteral nutrition.

According to the reports from the United States Food and Drug Administration Gattex is the third FDA-approved drug to treat adults with SBS and receiving nutritional support. Zorbtive (somatropin) and Nutrestore (glutamine) were approved in 2003 and 2004, respectively.

While talking to newspersons and medical experts, Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA Center for Drug Evaluation and Research, says that “today’s approval of Gettex would expand the available treatment options for patients with life-threatening condition” She also added that “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 US Food and Drug Administration the safety and efficacy of the Gattex and its tolerability were evaluated in two clinical trials and two extension studies. Patients in the trials were randomly assigned to receive Gattex or a placebo. The clinical trials were designed to measure the number of patients who achieved at least 20 percent reduction in the volume of weekly parenteral nutrition after 20 and 24 weeks of treatment (clinical response). Forty-six percent and 63 percent of patients treated with Gattex achieved clinical response, versus 6 percent and 30 percent of patients treated with placebo.

About GATTEX® (teduglutide)

GATTEX (teduglutide) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. GATTEX is in Phase 3 development for adult patients with short bowel syndrome (SBS). NPS has reported findings from completed studies in which GATTEX was found to effectively and safely reduce parenteral support (PS) volume in adult short bowel syndrome patients. Given GATTEX’s mechanism of action, NPS believes it has the potential to treat gastrointestinal conditions associated with intestinal failure.