Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’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.
“By reaching this key milestone in the approval process, we are pleased to take another step forward with Toujeo, an investigational new basal insulin that has been evaluated in a broad range of people living with diabetes,” said Pierre Chancel, senior vice president, Global Diabetes at Sanofi. “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.”
The NDA for Toujeo is based on results from the EDITION clinical trial program, which is a worldwide and extensive series of Phase 3 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.
Date: July 8, 2014