The Food and Drug Administration (FDA) has expanded the indication of Gattex (teduglutide; Shire) for injection in pediatric patients ≥1 year with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support [PS]).
The FDA approval was based on a 24-week pediatric study that included 59 patients aged 1 to 17 years who were randomized to either Gattex 0.025mg/kg/day (n=24), 0.05mg/kg/day (n=26), or standard of care (SOC). The primary endpoint was the number of participants who achieved at least a 20% reduction in weight-normalized average daily parenteral nutrition intravenous (PN/IV) volume at Week 24.
Results found that 18 patients who received Gattex 0.05mg/kg/day reduced PS volume by 20% or more and 10 patients were able to reduce PS infusion by at least 1 day per week. Additionally, 3 out of 26 children who received Gattex 0.05mg/kg/day completely weaned off PS.
Gattex is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), which helps to improve intestinal absorption of nutrients. It has demonstrated a safety profile that is similar in pediatric and adult patients.
“As the first US-approved therapy in pediatric SBS patients dependent on PS that improves absorption […] This approval underscores Takeda’s commitment to patients with rare and devastating GI conditions like SBS,” said Andrew Grimm, Global Clinical Development Lead, Takeda.
For more information visit Gattex.com.
This article originally appeared on MPR