Sanofi secures expanded European approval for Toujeo in type 1 diabetes
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.
Additionally, the therapy also demonstrated a comparable risk of low blood sugar events.
“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,” explained Dr Alok Gupta, Consultant Paediatric and Clinical Director at Darent Valley Hospital and Co-Chair for London and South East Coast Children Diabetes Regional Networks. “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 licence decision is welcome news as it expands the treatment options we have available for this patient population.”
Professor Mike Baxter, Medical Therapy Expert for Sanofi, also commented on the data: “Sanofi is committed to supporting people with diabetes in controlling their condition and reaching their treatment goals. The decision to extend the licence 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.”
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