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The U.S. Food and Drug Administration (FDA) approved an expanded indication for Sanofi’s Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages six years and older. This applies to both type 1 and 2 diabetes. Previously, Toujeo was approved only for adults aged 18 years and older.

The company announced the results of the EDITION JUNIOR clinical trial earlier in the month. It was the first randomized, controlled trial to compare Toujeo to Gla-100 in this patient population. The trial met its primary endpoint, demonstrating comparable decreases in average blood sugar over six months with both treatments and similar risk of low blood sugar events (hypoglycemia). In fact, the proportion of patients experiencing severe low blood sugar events and high blood sugar (hyperglycemia) with ketosis was numerically lower with Toujeo.

Based on the data, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use recommended the expanded label in Europe.

“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%,” said Dietmar Berger, Global Head of Development at Sanofi, at the time. “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.”

The EDITION JUNIOR study compared Toujeo to Gla-100 in 463 children and adolescents aged six to 17 years who had type 1 diabetes. They were evaluated for at least one year. They had HbA1C levels between 7.5% and 11.0% at the time of screening. The patients continued to use their existing mealtime insulin throughout the study.

The primary endpoint was non-inferior reduction of HbA1C after 26 weeks.

Insulin glargine injection is a long-acting, manufactured insulin. The injection holds three times as much insulin in 1ml as a standard 100 units/ml insulin.

Toujeo was originally approved for adults by the FDA in February 2015. Its primary competition is Novo Nordisk’s ultra-long-acting degludec, marketed as Tresiba. Both Toujeo and Tresiba are dosed once daily. The original insulin glargine is marketed by Sanofi as Lantus. It is facing competition from Boehringer Ingelheim’s Basaglar, the first insulin glargine follow-on approved by the FDA. It launched in 2016 after a patent battle with Sanofi.

In 2018, Toujeo brought in $840 million, while its Lantus sales dropped from $4.63 billion to $3.57 billion. Novo Nordisk’s Tresiba brought in $1.22 billion in 2018.

“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,” said Thomas Danne, director of the Department of General Pediatrics and Endocrinology/Diabetology at the Children’s Hospital on the Bult, Hannover Medical School, Germany. “In addition to the trial demonstrating safety and efficacy, the percentage of patients with severe hypoglycemia, and the percentage with hyperglycemia with ketosis, were numerically lower with Toujeo.”