FDA accepts NDA for Toujeo for Diabetes- Sanofi

Sanofi has announced that the FDA has accepted for review the company�s New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), formerly U 300, an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27, 2014.

The NDA for Toujeo is based on results from the EDITION clinical trial program, which is a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo in over 3,500 people from broad and diverse diabetes populations.