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The US Food and Drug Administration (FDA) has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with type 1 diabetes.
Last month, Sanofi reported positive results from the phase 3 EDITION JUNIOR trial of Toujeo in children and adolescents with type 1 diabetes. These were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts.
In the trial, 463 children and adolescents (aged 6 to 17 years) treated for type 1 diabetes for at least 1 year and with A1c between 7.5% and 11.0% at screening were randomized to Toujeo or insulin glargine 100 units/mL (Gla-100); partcipants continued to take their existing mealtime insulin.
The primary endpoint was noninferior reduction in A1c after 26 weeks.
The study met its primary endpoint, confirming a noninferior reduction in A1c with Toujeo versus Gla-100 after 26 weeks (mean reduction, 0.4% vs 0.4%; difference, 0.004%; 95% CI, –0.17 to 0.18; upper bound was below the prespecified noninferiority margin of 0.3%).
Over 26 weeks, a comparable number of patients in each group experienced one or more hypoglycemic events documented at anytime over 24 hours. Numerically fewer patients taking Toujeo experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking Gla-100.
No unexpected safety concerns were reported based on the established profiles of both products, the company said.
In October, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Toujeo for children age 6 years and older with diabetes.