FDA Approves Labeling Update for Gattex Injection

FDA Approves Labeling Update for Gattex Injection
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.

RELATED: FDA to Review Gattex sNDA for Short Bowel Syndrome

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.

For more information call (855) 542-8839 or visit Gattex.com.

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