French drugmaker Sanofi (SNYNF, SNY) Tuesday said the U.S. Food and Drug Administration accepted for review the company's New Drug Application or NDA for Toujeo or 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 for EU countries on May 27.
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.
Toujeo is the trade name for insulin glargine [rDNA origin] injection, 300 U/mL, formerly abbreviated as "U300". U300 is not currently approved or licensed anywhere in the world.
Pierre Chancel, Senior Vice President, Global Diabetes at Sanofi, said, "With the FDA's acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for Toujeo in the U.S. in the first half of 2015."
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