The approval was on based data from the EDITION clinical trial program, which included a series of international Phase III trials evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations (type 1 and type 2).
In this clinical trial program, the once-daily Toujeo was compared to once-daily Lantus (insulin glargine [rDNA origin] injection, 100U/mL) in open-label, randomized, active-control, parallel, treat-to-target trials for up to 26 weeks of duration with six months safety extension.
Sanofi Global Diabetes senior vice-president Pierre Chancel said: "Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the management of their diabetes for more than a decade.
"With the FDA approval of Toujeo, Sanofi builds on its strong legacy and looks forward to bringing a new treatment option to people living with diabetes."
All trials in the EDITION program successfully met the primary endpoints by showing similar blood sugar control with Toujeo as compared to Lantus.
According to the company, Toujeo is expected to be available in the US at the beginning of the second quarter of 2015.