The United States Food and Drug Administration (FDA) has approved Japan-based Takeda Pharmaceuticals' extension of the indication of GATTEX (teduglutide) for injection to paediatric patients one year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding, it was reported yesterday.

The product is claimed to be the first and only medicine that mimics naturally occurring glucagon-like peptide-2 (GLP-2), which helps the remaining intestine absorb more nutrients. In a pharmacodynamic study in adults, the product was shown to improve the amount of fluids absorbed by the intestines.

In a 24-week paediatric study, the product helped decrease the volume of daily parenteral support required and time spent administering parenteral support. Some children even achieved complete freedom from parenteral support. Fifty-nine paediatric patients with SBS aged one year to 17 years chose whether to receive the product or standard of care. Patients who chose to receive the product treatment were subsequently randomised in a double-blind manner to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while nine patients enrolled in the standard of care arm. The recommended dosage of the product is 0.05 mg/kg/day. Randomisation to the GATTEX dose groups was stratified by age.