Sanofi announced that the FDA has accepted for review its New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin]) injection, an investigational basal insulin.
The NDA submission for Toujeo was based on results from the EDITION clinical trial program, which consisted of an extensive series of phase 3 studies evaluating the efficacy and safety of Toujeo in over 3,500 people from broad and diverse diabetes populations.
Results from EDITION I (basal insulin plus mealtime insulin), EDITION II (basal insulin plus oral therapy), EDITION III, EDITION IV, EDITION JP I, and EDITION JP II (Japanese type 2 diabetes patients treated with basal insulin plus oral therapy) have already been presented.
For more information call (800) 446-6267 or visit Sanofi-Aventis.us.
This article originally appeared on MPR