10 January 2020 - Sanofi has revealed that the European Commission has expanded the existing label for Toujeo (insulin glargine 300 units/mL) to include the treatment of children and adolescent patients with diabetes, after the drug met its primary endpoint of non-inferiority compared to insulin glargine 100 units/mL (Gla-100).

The decision means that the drug is now authorised for use in adults, adolescents and children over the age of six with diabetes mellitus. 

It was based on Phase 3 data illustrating that Toujeo generated a comparable reduction in average blood sugar (HbA1c) levels compared to Gla-100; 6% of Toujeo patients experienced severe hypoglycaemia compared to 8.8% with Gla-100, and 8.2% experienced hyperglycaemia with ketosis compared to 11.4% with Gla-100.

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