European regulators have approved the use of Shire's Restive in children with short bowel syndrome (SBS), a rare and potentially life-threatening gastrointestinal condition.
Restive (teduglutide) is a glucagon-like peptide-2 (GLP-2) analogue first approved back in 2012 for adults with the condition, which is characterised by a clinically significant reduction in intestinal absorptive capacity because of surgical removal of large portions bowel, because of congenital abnormalities, disease or trauma.
The European Commission has now expanded the drug's scope to include the treatment of patients aged one year and above, on the back of data from a 12-week, open-label, multicentre, safety, pharmacokinetic and pharmacodynamic study was conducted in 42 children.
Although the study was not powered for efficacy, the data showed that children treated with the drug 0.05 mg/kg/day and 0.025 mg/kg/day had reductions from baseline to week 12 in parenteral support (intravenous feeding) volume requirements, and increases from baseline in enteral nutrition volume.
No deaths were reported, no serious drug-related adverse events were observed, and no patient discontinued the study due to adverse events, Shire noted.