FDA Accepts Sanofi’s NDA for New Basal Insulin, Toujeo

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The U.S. Food and Drug Administration (FDA) has accepted for review Sanofi’s New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), 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. 

 
Toujeo is the trade name for insulin glargine [rDNA origin] injection, 300 U/mL; formerly abbreviated as “U300”. Toujeo is an improved version of Sanofi’s popular basal insulin, Lantus.
 
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. 
 
Sanofi expects the regulatory decision for marketing authorization for Toujeo in the U.S. in the first half of 2015.
 
Toujeo (U300) is not currently approved or licensed anywhere in the world.

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