FDA Accepts Investigational Basal Insulin NDA for Review

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.

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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 + mealtime insulin), EDITION II (basal insulin + oral therapy), EDITION III, EDITION IV, EDITION JP I, and EDITION JP II (Japanese type 2 diabetes patients treated with basal insulin + oral therapy) have already been presented.

For more information call (800) 446-6267 or visit Sanofi-Aventis.us.

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