The US FDA has approved once-weekly exenatide extended-release for use in children with type 2 diabetes aged 10 years and above, stated AstraZeneca.

The drug is already approved in adults, and has now been approved for pediatric patients aged between 10 and 17 years with type 2 diabetes, as an adjunct to diet and exercise, thus making it the first once-weekly GLP-1 receptor agonist cleared for use in children and adolescents. The approval came after the results of the phase III BCB114 trial. The study participants receiving the treatment had a 0.25% reduction in HbA1c compared to an average 0.45% increase for those who received a placebo (between-group difference -0.85%; P<0.05). Additionally, investigators noted non-significant trends toward better outcomes for fasting glucose (-21.6 mg/dL), body weight (-1.22 kg), and systolic blood pressure (-2.8 mmHg4) with active exenatide… (Medpage Today)