Sanofi's Toujeo injection product granted FDA approval

PARIS — Sanofi on Thursday announced that the Food and Drug Administration approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily basal insulin to improve glycemic control in adults with Type 1 and Type 2 diabetes. Sanofi expects the drug to be available in the United States at the beginning of second-quarter 2015. 

 

Toujeo's approval is based on results from the Edition clinical trial program, which evaluated the efficacy and safety of the drug in more than 3,500 adults from broad diabetes populations.  According to Sanofi, "once-daily Toujeo was compared to that of once-daily Lantus (insulin glargine [rDNA origin] injection, 100 U/mL) in open-label, randomized, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with 6 months safety extension."

 

Toujeo will be available in the Toujeo SoloStar, a prefilled pen containing 450 units of the drug. It requires a third of the injection volume to deliver the same amount of insulin units as compared to Lantus SoloStar. 

 

"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," said Pierre Chancel, SVP global diabetes, Sanofi.