Biopharmaceutical company Takeda Pharmaceuticals USA Inc said on Friday that the US Food and Drug Administration (FDA) has extended the indication of GATTEX (teduglutide) for injection to paediatric patients with Short Bowel Syndrome (SBS).

In children, SBS is a life-threatening, chronic and rare malabsorption disorder resulting from surgical removal of a large portion of the intestine, which is typically due to congenital or acquired conditions of the newborn or trauma. Children with SBS are unable to absorb enough nutrients and fluids from what they eat and drink alone.

The US FDA has authorised the marketing of the extended 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 (parenteral support). The SBS treatment will restore the remaining intestine's ability to absorb nutrients and reduce long-term dependence on parenteral support (PS).

According to the company, GATTEX is the first and only medicine that mimics naturally occurring glucagon-like peptide-2 (GLP-2), which helps the remaining intestine absorb more nutrients. GATTEX (teduglutide) is a recombinant analog of human glucagon-like peptide-2.

Under the company's 24-week paediatric study, GATTEX helped reduce the volume of daily PS required and time spent administering PS. Some children even achieved complete freedom from PS. The recommended dosage of GATTEX is 0.05 mg/kg/day. Randomisation to the GATTEX dose groups was stratified by age. GATTEX has been shown to help some children wean off of intravenous nutrition over time during clinical studies.

GATTEX has a demonstrated safety profile that is similar overall in paediatric and adult patients. At the end of the 24-week study, 69% of patients who took GATTEX 0.05 mg/kg each day reduced PS volume by 20% or more, concluded the company.