Results from a Phase 3 clinical trial, EDITION JUNIOR, evaluating Sanofi’s (NASDAQ:SNY) Toujeo (insulin glargine 300 Units/mL) in children and adolescents with type 1 diabetes (T1D) showed it to be comparable to Lantus (insulin glargine 100 Units/mL) as measured by the change in HbA1c from baseline to month 6 with similar risk of hypoglycemic events. The data were presented at the International Society for Pediatric and Adolescent Diabetes Annual Conference in Boston.
The company’s European application seeking approval to expand the labeling to include children as young as six years old is pending final approval by the European Commission, expected no later than December.
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