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Sanofi: Positive Toujeo Study Results In 6 To 17 Years With Type 1 Diabetes

Sanofi (SNYNF,SNY) announced Monday positive results in Phase 3 trial for Toujeo in children and adolescents with type 1 diabetes.

The French drug maker in a statement noted that children and adolescents, aged 6 to 17 years, living with type 1 diabetes achieved comparable reduction in average blood sugar or HbA1c and similar risk of low blood sugar events with Toujeo (insulin glargine 300 Units/mL) compared to insulin glargine 100 Units/mL (Gla-100).

The trial, EDITION JUNIOR, is the first randomized, controlled trial comparing Toujeo vs Gla-100 in this group of patients. The study met its primary endpoint with comparable reductions in average blood sugar over 6 months with both treatments and similar risk of low blood sugar events or hypoglycemia.

The results were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts.

The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion on October 17, recommending expanding the current indication for Toujeo in the Europe Union for the treatment of diabetes mellitus in adolescents and children.

The European Commission will make a final decision on the additional indication in the coming months.

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