Sanofi has received approval from the US Food and Drug Administration (FDA) for its Toujeo (insulin glargine [rDNA origin] injection, 300U/mL).
Toujeo is an once-daily long-acting basal insulin developed to improve glycemic control in adults with type I and type II diabetes.
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."
Approval was based on results from the Edition clinical trial programme, which included a series of international Phase III studies assessing the efficacy and safety of Toujeo in around 3,500 adults from a wide range diabetes populations, including type I and type II.
The once-daily Toujeo was compared against once-daily Lantus (insulin glargine [rDNA origin] injection in open-label, randomised, active-control, parallel and treat-to-target studies of up to 26 weeks of duration with six months safety extension.
According to Sanofi, Edition programme’s all studies met the primary study endpoints by showing similar blood sugar control with Toujeo as compared with Lantus.
The company plans to begin selling Toujeo in the US from the second quarter of this year.