Toujeo (insulin glargine [rDNA origin] injection) is EU approved for treatment of diabetes- Sanofi

Sanofi has announced that the European Commission has granted marketing authorization in Europe for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal insulin for the treatment of type 1 and type 2 diabetes mellitus in adults. The European Commission's decision to grant marketing authorization in Europe for Toujeo is based on results from the EDITION clinical trial program, a series of worldwide Phase III studies evaluating the efficacy and safety of Toujeo compared with Lantus (insulin glargine [rDNA origin] injection, 100 U/mL) in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy.

Blood sugar control with Toujeo was comparable to Lantus, with a favorable safety profile. The incidence of confirmed hypoglycemia was lower with Toujeo as compared to Lantus, both at any time of the day and at night, in people with type 2 diabetes. Toujeo also demonstrated more stable and more predictable glycemic control and low within-individual blood sugar variability that lasted beyond 24 hours compared with Lantus in people with type 1 diabetes.

Comment:Toujeo is an essential improvement, as an estimated 15-20% of type 1 diabetic patients are currently not well controlled on Lantus. The relatively short half-life of Lantus of around 12 hours can also be a problem for some type 2 diabetic patients, who have to inject twice a day or use supplemental insulin to manage their blood glucose. Toujeo will offer prolonged duration of action and reduced nocturnal hypoglycemia rates.