FDA to Review New Drug Application (NDA) for Touejo

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FDA to Review New Drug Application (NDA) for Touejo
FDA to Review New Drug Application (NDA) for Touejo

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.

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