The FDA has approved Toujeo (insulin glargine injection 300 U/mL; Sanofi) — a once-daily long-acting basal insulin — to improve glycemic control in adults with type 1 and type 2 diabetes, according to a press release from the manufacturer.
The agency based its approval of Toujeo on a review of data from the EDITION clinical trial program, which consisted of a series of international phase 3 studies evaluating the safety and efficacy of Toujeo in more than 3,500 adults with type 1 and type 2 diabetes.
In the program, once-daily Toujeo was compared with once-daily Lantus (insulin glargine injection, 100 U/mL) in open-label, randomized, active-control, parallel, treat-to-target studies for up to 26 weeks of duration with 6 months safety extension.
Results from the EDITION program showed that all studies met the primary endpoint of demonstrating similar blood glucose control with Toujeo vs. Lantus. Excluding hypoglycemia, the most common adverse events with Toujeo were nasopharyngitis and upper respiratory tract infection.
“Nearly 50% of people living with diabetes remain uncontrolled,” John Anderson, MD, internal medicine and diabetes specialist, Frist Clinic of Nashville, Tennessee, and Past President of the American Diabetes Association, said in the release.
“Despite the proven efficacy of insulin, ensuring effective titration and maintenance can be a challenge for both patients and health care professionals due to hypoglycemia concerns. Toujeo provides a new option that may help patients manage their diabetes.”
Toujeo will be available in the Toujeo SoloSTAR, which is a disposable prefilled pen containing 450 units of Toujeo.