FDA Approves Insulin Glargine Injection for Pediatric Patients with Diabetes

Officials with the FDA have approved an expanded indication for insulin glargine injection (Toujeo, Sanofi) 300 Units/ml as a long-acting insulin to improve blood sugar control in adult and pediatric patients, age 6 years and older, with diabetes.¹

The drug was previously approved by the agency for improving blood sugar control only in adults aged 18 years and older.¹

The approval was based on a phase 3 EDITION JUNIOR trial evaluating children and adolescents, aged 6 to 17, living with type 1 diabetes and existing phase III clinical trial data from adults with type 1 and type 2 diabetes (EDITION trial program). ¹

The EDITION JUNIOR was the first randomized, controlled trial comparing insulin glargine injection 300 units/ml vs. insulin glargine 100 Units/ml. The study results were presented at the International Society of Pediatric and Adolescent Diabetes 45^th Annual Conference in Boston, MA.²

The EDITION JUNIOR study included 463 children and adolescents (aged 6 to 17 years) treated for type 1 diabetes for at least one year and with comparable reduction in average blood sugar between 7.5% and 11.0% at screening. Participants continued to use their existing mealtime insulin. The trial demonstrated that participants with insulin glargine 300 units/ml experienced numerically lower severe hypoglycemia and hyperglycemia compared with those who were assigned to 100 units/ml.²

Insulin glargine injection is a long-acting man-made insulin used to control high blood sugar in adults and children who are 6 years of age or older with diabetes mellitus. The injection contains 3 times as much insulin in 1ml as standard insulin (100 units/ml). ¹

The most common adverse effects reported with insulin glargine injection is hypoglycemia. Additional allergic reactions may occur, including a rash over the whole body, shortness of breath, swelling of face, tongue or throat, or trouble breathing. ¹

REFERENCES

• FDA Approval of Sanofi’s Toujeo for Pediatric Patients [email]. Ruder Finn. Sent November 26, 2019. Accessed November 26, 2019.
• Danne T et al., “Insulin Glargine 300 U/mL (Gla-300) provides effective glycemic control in youths with type 1 diabetes (T1D): the EDITION JUNIOR study,” Poster presentation P240, ISPAD 45th Annual Conference, Boston MA; October 31, 2019. http://www.professionalabstracts.com/ispad2019/Iplanner/#/presentation/216. Accessed November 26, 2019.