Sanofi’s next-generation long-acting basal insulin Toujeo has been approved for diabetes in the European Union, offering patients a new treatment option with a lower risk of hypoglycaemia.
The green light from the European Commission was based on data from the EDITION Phase III clinical trial program, which pitted the efficacy and safety of Toujeo against that of Sanofi’s older insulin Lantus in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy.
Results showed that Toujeo’s blood sugar control was comparable to Lantus’, but that is safety profile was favourable, with a lower incidence of confirmed hypoglycaemia day and at night type II diabetics.
Toujeo also offered more stable and more predictable glycaemic control and low within-individual blood sugar variability that lasted beyond 24 hours compared with Lantus in people with type 1 diabetes, Sanofi said.
A huge proportion of diabetes patients (around 50% globally) on insulin are still failing to achieve adequate blood sugar control, and the firm is hoping that the efficacy and safety advantages offered by Toujeo could help address some of this unmet need.