Liraglutide for children with type 2 DMAugust 6, 2019
The US FDA has approved liraglutide (Victoza) injection for the treatment of paediatric patients 10 years or older with type 2 diabetes.
Lliraglutide is the first non-insulin drug approved to treat type 2 diabetes in paediatric patients since metformin was approved for paediatric use in 2000. The drug has been approved to treat adult patients with type 2 diabetes since 2010.
The FDA granted this application Priority Review.
The efficacy and safety of liraglutide for reducing blood sugar in patients with type 2 diabetes was studied in several placebo-controlled trials in adults and one placebo-controlled trial with 134 paediatric patients 10 years and older for more than 26 weeks.
Approximately 64% of patients in the paediatric study had a reduction in their haemoglobin A1c (HbA1c) below 7% while on liraglutide, compared to only 37% who achieved these results with the placebo.
These results occurred regardless of whether the patient also took insulin at the same time. Adult patients who took liraglutide with insulin or other drugs that increase the amount of insulin the body makes (e.g., sulfonylurea) may have an increased risk of hypoglycaemia.
Meanwhile, paediatric patients 10 years and older taking liraglutide had a higher risk of hypoglycaemia regardless of whether they took other therapies for diabetes.