The Food and Drug Administration (FDA) has expanded the indication for Toujeo (insulin glargine; Sanofi) 300 Units/mL to include treatment of pediatric patients aged ≥6 years with diabetes mellitus. Previously, Toujeo was indicated for use in adults aged ≥18 years.
The approval was based on data from the phase 3, randomized, open-label, multicenter EDITION JUNIOR trial that compared the efficacy of Toujeo 300 Units/mL to Lantus (insulin glargine) 100 Units/mL in 463 patients aged 6 to 17 years with type 1 diabetes for at least 1 year. The primary end point was the change from baseline in HbA1c to Month 6. Results showed an adjusted mean change from baseline in HbA1c of -0.386% with Toujeo vs -0.404% with Lantus (adjusted mean difference: 0.018; 95% CI -0.159, 0.195).
With regard to safety, a similar percentage of patients in both groups experienced ≥1 event of severe and/or documented (≤70mg/dL) hypoglycemia (97% and 97.8% for Toujeo 300 Units/mL and Lantus 100 Units/mL, respectively). Numerically, the percentage of patients who experienced severe hypoglycemia or had ≥1 event of hyperglycemia with ketosis (ketones ≥1.5mmol/L) was lower with Toujeo compared with Lantus.
Toujeo, a long-acting human insulin analog, is available as 1.5mL SoloStar and 3mL Max SoloStar prefilled pens in 3-count packs.
For more information visit sanofi.com.