CHMP recommends Toujeo (insulin glargine [rDNA origin]) for treatment of type 1 and type 2 diabetes-Sanofi

Sanofi has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycaemic control that lasts beyond 24 hours compared with Lantus (insulin glargine [rDNA origin] injection, 100 U/mL) with low within-individual, within-day blood sugar variability.

The CHMP positive opinion of Toujeo is based on results from the EDITION clinical trial programme, a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo compared to Lantus in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy. Toujeo demonstrated effective blood sugar control, with a favourable safety profile. Toujeo significantly lowered hypoglycaemic risk in people with type 2 diabetes both at any time of the day and night-time compared with Lantus.