FDA Approves Insulin Glargine for Pediatric Patients

The US Food and Drug Administration (FDA) has approved insulin glargine injection 300 Units/mL (Toujeo) for the management of blood sugar in adults and pediatric patients with diabetes, aged 6 years and older.

The approval for the Sanofi insulin therapy follows its indication to improve blood sugar control in diabetic adults aged 18 years and older in February 2015. The original indication was based on the findings of the EDITION clinical trial program, a series of phase 3 trials assessing the therapy’s efficacy and safety 3500-plus adults with either type 1 or 2 diabetes.

In addition to supplemental EDITION pediatric data, the pediatric-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.

Patients reported HbA1c levels between 7.5% and 11.0% at the time of screening, and had been treated for their diabetes for at least 1 year. Insulin glargine reported non-inferior reduction of blood sugar versus Gla-100 at 26 weeks (0.4% vs 0.4%; difference, .004%; 95% CI, -0.17 to 0.18).

Additionally over 26 weeks, a comparable rate of patients experienced 1 or more anytime documented hypoglycemia events. Fewer patients on insulin glargine experienced severe hypoglycemia, or experienced at least 1 hyperglycemia episode with ketosis.

At the time of the EDITION JUNIOR data, Dietmar Berger, Global Head of Development at Sanofi noted that 50% to 80% of young people living with type 1 diabetes were in need of better treatment options for them to achieve a mean blood sugar level below 7.5%.

“By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease,” he said in a statement.