FDA Approves Labeling Update for Gattex Injection

NPS Pharmaceuticals announced that the FDA has approved updated labeling for Gattex (teduglutide [rDNA origin]) for injection to include long-term data from the STEPS 2 study of adult patients with short bowel syndrome.

STEPS was a randomized, double-blind, placebo-controlled, parallel-group, multi-national, multi-center clinical trial in adults with short bowel syndrome who were dependent on parenteral nutrition/intravenous support for at least 12 months and required parenteral nutrition at least 3 times weekly. STEPS 2 was the 2-year open-label extension in which 88 patients received Gattex 0.05mg/kg/day.

Data from STEPS 2 showed that patients who continued Gattex treatment beyond 2 years achieved clinically meaningful reductions in parenteral support requirements, including volume and days off. Out of the 88 patients, 13 achieved complete independence.

Gattex for injection is available as a single-use vial containing 5mg of teduglutide in a 1- or 30-count kit.

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