Sanofi's Toujeo (Insulin Glargine 300 U/mL) Receives FDA Approval for Pediatric Use in Type 1 Diabetes

On November 27, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Sanofi announced the FDA approval of its insulin glargine injection, Toujeo, for the treatment of pediatric patients aged 6 years and older with type 1 diabetes. Previously, Toujeo was indicated only for adult patients aged 18 years and older with diabetes.

Toujeo is a long-acting insulin glargine injection with a concentration of 300 U/mL. In February 2015, the drug received FDA approval for the treatment of type 1 diabetes in adults. Toujeo’s primary competitor is Novo Nordisk’s ultra-long-acting therapeutic agent, degludec, marketed under the brand name Tresiba. In 2018, Toujeo generated $840 million in sales, while Tresiba recorded $1.22 billion in sales.

Sanofi conducted the first randomized controlled trial of Toujeo—the EDITION JUNIOR clinical trial—in patients with type 1 diabetes aged 6 to 17 years, to compare the clinical efficacy of Toujeo with insulin glargine 100 U/mL (Gla-100) in this patient population. The study evaluated the efficacy over one year in 463 pediatric and adolescent patients with type 1 diabetes.

In early November 2019, Sanofi presented data from the EDITION JUNIOR clinical study at the 45th Annual Conference of the International Society for Pediatric and Adolescent Diabetes (ISPAD). The trial demonstrated that patients treated with either Toujeo or Gla-100 experienced comparable reductions in mean blood glucose levels over six months, with similar risks of hypoglycemic events. Notably, the numerical incidence of severe hypoglycemia and hyperglycemia with ketosis was lower with Toujeo therapy. Based on these data, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) considered expanding the indication for Toujeo to include the treatment of type 1 diabetes in children and adolescents.

Sanofi (NYSE: SNY), founded in 1973 and headquartered in Paris, France, is a global leading pharmaceutical company. The company is primarily engaged in the development, manufacturing, and marketing of innovative medicines, providing innovative solutions for healthcare professionals and patients. Sanofi’s business areas cover diabetes solutions, vaccines, innovative medicines, consumer healthcare, and other emerging markets. Its products are used to treat thrombosis, cardiovascular diseases, diabetes, central nervous system disorders, oncology, and general medical conditions. Currently, the company operates in more than 100 countries and regions worldwide.

Thomas Danne, Director of the Department of General Pediatrics and Diabetology at the Children’s Hospital, stated, “Patients with type 1 diabetes must constantly monitor their blood glucose levels, and this disease poses a significant challenge to medicine. The clinical trial results for Tangdeshi are encouraging, demonstrating its therapeutic potential for pediatric patients with type 1 diabetes.”

Dietmar Berger, Global Head of Development at Sanofi, stated, “Between 50% and 80% of patients with type 1 diabetes worldwide require better treatment options to help bring their average blood glucose levels within the normal range. By investigating the pathogenesis of diabetes in children and adolescents, we aim to provide personalized treatment plans to help them achieve better disease control.”

(Compiled by Xu Xiaoxue)