Higher-dose insulin glargine for paediatric patientsFebruary 6, 2020
The US FDA has approved an expanded indication for insulin glargine injection 300 Units/mL (Toujeo) for the management of blood sugar in children aged 6 years and older with diabetes.
The approval for the insulin therapy follows its indication to improve blood sugar control in diabetic adults aged 18 years and older in February 2015.
The expanded indication was supported by the phase 3 EDITION JUNIOR trial evaluating children and adolescents aged 6 to 17 years with type 1 diabetes, and existing phase 3 clinical trial data from adults with type 1 and type 2 diabetes in the EDITION trial programme.
In addition to supplemental EDITION paediatric data, the paediatric-added indication was based on the positive findings of the phase 3 EDITION JUNIOR trial, in which 463 children and adolescents aged 6-17 with type 1 diabetes were evaluated for blood sugar control with insulin glargine.
The study compared the insulins in 463 children and adolescents treated for T1D for at least 1 year and with HbA1c between 7.5% and 11.0% at the screening.