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.

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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.

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