FDA Approves Insulin Glargine Injection for Pediatric Patients with Diabetes

Officials with the FDA have approved an expanded indication for insulin glargine injection (Toujeo, Sanofi) 300 Units/ml as a long-acting insulin to improve blood sugar control in adult and pediatric patients, age 6 years and older, with diabetes.1

The drug was previously approved by the agency for improving blood sugar control only in adults aged 18 years and older.1

The approval was based on a phase 3 EDITION JUNIOR trial evaluating children and adolescents, aged 6 to 17, living with type 1 diabetes and existing phase III clinical trial data from adults with type 1 and type 2 diabetes (EDITION trial program). 1

The EDITION JUNIOR was the first randomized, controlled trial comparing insulin glargine injection 300 units/ml vs. insulin glargine 100 Units/ml. The study results were presented at the International Society of Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, MA.2

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