The FDA on Tuesday approved an expanded indication for insulin glargine injection 300 U/mL to improve glucose response in children aged 6 years and older with diabetes, according to a press release from Sanofi.
Insulin glargine injection (Toujeo) 300 U/mL is a long-acting insulin previously approved to improve blood glucose in adults with diabetes.
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 program.
As Healio previously reported, in EDITION JUNIOR, children and adolescents with type 1 diabetes assigned insulin glargine injection 300 U/mL for 26 weeks experienced a reduction in HbA1c similar to that of children assigned insulin glargine 100 U/mL. Researchers also observed no difference in hypoglycemic events between treatment groups.
“EDITION JUNIOR demonstrated children and adolescents aged 6 to 17 years living with type 1 diabetes achieved comparable reduction in average blood glucose and similar risk of low blood sugar events with insulin glargine 300 U/mL compared with insulin glargine 100 U/mL,” Christopher Sorli, MD, PhD, vice president of U.S. medical affairs, head of cardio-metabolism at Sanofi, told Healio. “By taking this step toward investigating an additional option for children and adolescents living with type 1 diabetes, we hope to provide another treatment option for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease.”
The findings were presented at the International Society for Pediatric and Adolescent Diabetes Annual Meeting earlier this month. – by Regina Schaffer
Disclosures: The authors report no relevant financial disclosures.