Significant results from an international phase 3 study, EDITION, resulted in the approval of Toujeo in treating patients with type 1 as well as type 2 diabetes.
Sanofi announced today that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes mellitus. Toujeo is expected to be available in the United States at the beginning of Q2 2015.
"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, Senior VP, Global Diabetes, Sanofi.
The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international phase 3 studies evaluating the efficacy and safety of Toujeo in more than 3500 adults from broad and diverse diabetes populations (type 1 and type 2). In the clinical trial program leading to approval, 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.
Complete press release on PR Newswire: http://prn.to/1LJ2BmX