Toujeo Approved for Pediatric Patients With Diabetes – Monthly Prescribing Reference

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.

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Toujeo Approved for Pediatric Patients With Diabetes - Monthly Prescribing Reference