FDA to review NDA for Sanofi's new basal insulin
- Currently both FDA and EMA are reviewing the NDA for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL.
- The clinical trial program includes more than 3,500 diabetic patients.
- The goal is to gain approval in the first half of 2015.
If approved, Toujeo will be the first 300 U/mL basal insulin available. The goals of this new formulation are to provide better glycemic control with fewer hypoglycemic episodes, including nocturnal and diurnal episodes. The NDA for Toujeo is based on a global clinical trial program known as EDITION. Notably, Toujeo has been tested across age groups, various ethnic groups and in patients with type 1 and type 2 diabetes.
- Pharmaceutical Business Review FDA accepts to review Sanofi's NDA for diabetes drug Toujeo