Sanofi's Long-Acting Insulin Toujeo Receives FDA Approval for Expanded Use in Pediatric and Adolescent Patients with Type 1 Diabetes

Recently, the U.S. FDA approved an expansion of the indications for Sanofi’s long-acting insulin glargine injection, Toujeo, to include the treatment of children and adolescents aged 6 years and older with type 1 diabetes. Based on the results of the EDITION JUNIOR trial announced earlier this month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has also recommended approving the expanded indication. Previously, Toujeo was approved only for adult patients aged 18 years and older.

Type 1 diabetes, which is highly prevalent in children, is an autoimmune disease characterized by immune-mediated loss of pancreatic β-cell function. Statistics show that among individuals under the age of 18 in the United States, 1 in every 300 is affected by type 1 diabetes. As an insulin-dependent form of diabetes, it requires patients to frequently manage fluctuations in blood glucose levels; hyperglycemia can lead to ketosis and ketoacidosis, while hypoglycemia can result in hypoglycemic episodes. For children and adolescents, managing these blood glucose fluctuations is particularly challenging.

Toujeo is a long-acting insulin glargine injection with an insulin concentration three times that of standard insulin (100 units/mL), containing 300 units/mL. It was approved by the U.S. FDA for marketing in 2015. The primary activity of insulin is to regulate glucose metabolism, achieving blood glucose reduction by stimulating peripheral glucose uptake, particularly in skeletal muscle and adipose tissue, and by inhibiting hepatic glucose production.

This approval was primarily based on the results of a trial named EDITION JUNIOR. The trial aimed to verify the efficacy of Toujeo in treating patients aged 6 to 17 years with type 1 diabetes. The trial results showed that after 6 months of treatment, patients in the Toujeo group achieved the non-inferiority criterion for reducing glycated hemoglobin (HbA1c) levels compared to Toujeo Gla-100, meeting the study's primary endpoint. Additionally, the incidence of ketosis and severe hypoglycemia (<54 mg/dL) was relatively lower in this group, demonstrating its effectiveness in managing blood glucose fluctuations.

“Globally, 50% to 80% of patients with type 1 diabetes require additional treatment options to achieve the therapeutic goal of an HbA1c level below 7.5%,” said Dr. Dietmar Berger, Head of Global Development at Sanofi. “We aim to provide a new treatment option for children and adolescents with diabetes by conducting clinical studies in this population, helping them better manage their disease through personalized treatment regimens.”

References:

[1] FDA approves higher-dose insulin glargine for children with diabetes.

Retrieved November 27, 2019, from https://www.healio.com/endocrinology/diabetes/news/online/%7B02528175-3674-4f88-81ba-e06bb699cf9f%7D/fda-approves-higher-dose-insulin-glargine-for-children-with-diabetes

▽Follow [WuXi AppTecDe】WeChat Official Account