Promising Phase 3 data for Sanofi’s Toujeo secures CHMP recommendation of label expansion in type 1 diabetes
pharmafile | November 4, 2019 | News story | Research and Development, Sales and Marketing | EU, Sanofi, Type 1 diabetes, diabetes, pharma, toujeo
Sanofi took the opportunity at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts to reveal positive new Phase 3 data on Toujeo (insulin glargine 300 Units/mL) in paediatric and adolescent type 1 diabetes patients between six and 17 years old.
The study – the first of its kind to compare Toujeo to insulin glargine 100 Units/mL (Gla-100) in this population – was revealed to have met its primary endpoint, with Sanofi’s therapy proving comparable in average blood sugar reduction over six months, and also in risk of low blood sugar events.
Additionally, a “numerically lower” rate of Toujeo patients experienced severe hypoglycaemia and high blood sugar with ketosis.
Sanofi also revealed that these same data had led to the European Medicines Agency’s Committee for Medicinal Products for Human Use to reach a positive stance on the drug, giving its positive recommendation to expand Toujeo’s existing indication to cover the treatment of diabetes mellitus in adolescents and children six years and older. A final decision is expected from the European Commission in the coming months.
“We know that living with type 1 diabetes means dealing with highs and lows in blood sugar, which are worrying and present substantial challenges for young people,” exoplained Professor Dr Thomas Danne, Director of the Department of General Pediatrics and Endocrinology/Diabetology at the Children’s Hospital on the Bult, Hannover Medical School. “In addition to the trial demonstrating safety and efficacy, the percentage of patients with severe hypoglycemia, and the percentage with hyperglycaemia with ketosis, were numerically lower with Toujeo.”
Global Head of Development at Sanofi, Dietmar Berger, also commented: “Across the globe, between 50 and 80% of young people living with type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5%,” “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.”
Matt Fellows
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