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FDA Approves Toujeo for Children with Diabetes

The FDA recently approved a higher-dose insulin glargine 300 U/mL Toujeo for children 6 and older with type 1 or type 2 diabetes. The European Medicines Agency also approved its expanded use in Europe. 

What is Toujeo?

Insulin glargine (brand name Toujeo, made by Sanofi) is a long-acting form of insulin analog that was approved for adults 18 and older in 2015. Toujeo is a once-daily dose, and its top competitor is Tresiba by Novo Nordisk. 


Clinical trials prove efficacy

This FDA approval comes as a result of the phase 3 EDITION JUNIOR clinical trial, which compared Toujeo (300 U/mL) to Lantus (100 U/mL) in children aged 6 to 17 with type 1, in whom Toujeo was effective. Both Toujeo and Lantus were safe to use as well as equally effective in helping children achieve ideal HbA1c levels. The phase 3 EDITION trial tested the insulin in adults with type 1 and type 2 diabetes.  

The approval of Toujeo for kids expands the options for treatment available for children. Dietmar Berger, Global Head of Development at Sanofi, said: “Across the globe, between 50 and 80 percent of young people living with type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5 percent. By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease.” 

Toujeo is available as 1.5 mL SoloStar or 3 mL Max SoloStar pens in 3-packs. 

Insulin for diabetes

Insulin is a powerful hormone produced by beta cells in the pancreas that helps cells turn blood glucose into energy. When the body either doesn’t make insulin or doesn’t respond to it, the complications of diabetes arise.

Everyone with type 1 and some people with type 2 diabetes need to use insulin to manage their diabetes. People with type 1 diabetes have to take insulin because their pancreas no longer produces it. Some people with type 2 diabetes need to take insulin, as they have insulin resistance, wherein their sensitivity to insulin is impaired.