The Food and Drug Administration has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with.
The FDA first approved Toujeo in 2015 for adults with type 1 and, designed as a more potent follow-up to Sanofi’s top-selling (Lantus).
Last month, Sanofi reportedfrom the phase 3 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.
In the trial, 463 children and adolescents (aged 6-17 years) treated for type 1 diabetes for at least 1 year and withbetween 7.5% and 11.0% at screening were randomized to Toujeo or glargine 100 units/mL (Gla-100); participants 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% confidence interval, –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 severeor 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 2019, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of Toujeo for children age 6 years and older with diabetes.
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