Toujeo Receives Expanded Indication

November 25, 2019 – The U.S. FDA has approved an expanded indication for Toujeo® (insulin glargine injection) 300 Units/mL, manufactured by Sanofi, to improve glycemic control in patients as young as six years old who have diabetes mellitus. Previously, the product was indicated only for use by adults.

Diabetes is a chronic condition in which the body is unable to make enough insulin or has trouble using the insulin it produces. Insulin is needed to keep blood sugar levels from becoming too high. Patients who have type 1 diabetes, which is often diagnosed during childhood, must take insulin daily to survive. This is because the body is unable to make enough insulin of its own. In type 2 diabetes, the body has difficulty using the insulin it makes. This type of diabetes previously occurred primarily in adults, but its incidence in pediatric patients is increasing. Some but not all patients who have type 2 diabetes require insulin as part of their treatment regimen.

In a clinical trial, Toujeo and Sanofi’s Lantus® (insulin glargine injection) 100 Units/mL – a product already approved for use in pediatric patients – delivered similar results in children and adolescents who have type 1 diabetes. Although the two products contain the same active ingredient, Toujeo is a more concentrated form. This allows patients to use a lower injection volume compared to Lantus and produces a longer duration of action.

Toujeo is available in 1.5mL and 3mL SoloStar single-patient-use prefilled pens for subcutaneous injection daily at any time during the day, at the same time every day. The daily dose should be individualized based on the type of diabetes, the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. Blood glucose must be closely monitored when beginning a patient on Toujeo and during the initial weeks of treatment with the product. Patients can self-administer the drug if properly trained in its use and administration technique.