FDA expands use of insulin glargine to childhood diabetes

FDA expanded the indication for insulin glargine 300 units/mL injection (Toujeo—Sanofi) to include children as young as age 6 years with type 1 diabetes. FDA initially approved the longer lasting insulin glargine injection in 2015 for adults with type 1 and type 2 diabetes.

FDA expanded the indication for insulin glargine 300 units/mL injection (Toujeo—Sanofi) to include children as young as age 6 years with type 1 diabetes.

FDA initially approved the longer lasting insulin glargine injection in 2015 for adults with type 1 and type 2 diabetes.

Sanofi reported positive results from the Phase III EDITION JUNIOR trial of insulin glargine in children and adolescents with type 1 diabetes, as presented in November at the International Society for Pediatric and Adolescent Diabetes annual conference in Boston. In the trial, 463 children and adolescents between aged 6-17 years, who were treated for type 1 diabetes for at least 1 year and with blood glucose levels between 7.5% and 11.0% at screening, were randomized to receive either insulin glargine 300 units/mL injection or insulin glargine 100 units/mL.

The drugs were administered to participants alongside their current mealtime insulin. The primary endpoint was noninferior reduction in blood glucose after 26 weeks. The researchers found that fewer patients taking insulin glargine 300 units/mL injection experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking insulin glargine 100 units/mL. The company says no unexpected safety concerns were reported based on the established profiles of both products.

DECEMBER 5, 2019

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