Toujeo® gets European approval for children and teenager use
Toujeo® (insulin glargine 300 units/mL) can now be used to treat children and teenagers with type 1 diabetes, pharmaceutical giant Sanofi has announced.
The European Commission (EC) has approved the medication to be used in children from the age of six years.
The decision has been made following positive results in a Phase 3 trial. The findings found children and adolescents living with type 1 diabetes achieved comparable reduction in average blood sugar (HbA1c) and similar risk of low blood sugar events with Toujeo® when compared to insulin glargine 100 Units/mL (Gla-100).
Based on trial data, we can see that Toujeo may present a valuable treatment for many children and adolescents living with diabetes in the UK Dr Alok Gupta
Dr Alok Gupta, Consultant Paediatric and Clinical Director, Darent Valley Hospital and Co-Chair for London and South East Coast Children Diabetes Regional Networks said: “Diabetes is a long-term condition which is becoming more common in the UK. It can have a major impact on the life of a young person, as well as those around them.
“Based on trial data, we can see that Toujeo may present a valuable treatment for many children and adolescents living with diabetes in the UK. The license decision is welcome news as it expands the treatment options we have available for this patient population.”
EDITION JUNIOR, is the first randomised, controlled trial comparing Toujeo® vs Gla-100 in this group of people.
The study met its primary endpoint of demonstrating non-inferiority vs Gla-100 change in HbA1c from baseline at week 26. T
oujeo® provided similar glycemic control to Gla-100 in children and adolescents with type 1 diabetes, as well as similar risk of low blood sugar events (hypoglycemia).
The percentages of people who experienced severe hypoglycemia and who experienced high blood sugar (hyperglycemia) with ketosis were numerically lower with Toujeo® vs Gla-100 (6% vs 8.8% and 8.2% vs 11.4%, respectively). As these are serious short-term complications, these findings may be clinically important for people with type 1 diabetes.
Professor Mike Baxter, Medical Therapy Expert for Sanofi said: “Sanofi is committed to supporting people with diabetes in controlling their condition and reaching their treatment goals. The decision to extend the license indication to children and adolescence expands the population of patients who can benefit from Toujeo and provides a new treatment option for many young people living with diabetes.”
Picture credit:Robert Collins