02.26.15
Sanofi received approval from the FDA for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of 2Q15.
The approval was based on results from the EDITION clinical trial program evaluating the efficacy and safety of Toujeo in more than 3,500 adults with type 1 and type 2 diabetes. All studies in the program successfully met the primary endpoints, demonstrating similar blood sugar control with Toujeo as compared to Lantus.The most common adverse events included nasopharyngitis (12.8% in type 1 patients and 7.1% in type 2 patients) and upper respiratory tract infection (9.5% in type 1 patients and 5.7% in type 2 patients).
Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen containing 450 units of Toujeo, which requires one third of the injection volume to deliver the same number of insulin units as compared to the company's Lantus SoloSTAR. Toujeo is currently pending marketing authorization with the EMA and other health authorities around the world.
The approval was based on results from the EDITION clinical trial program evaluating the efficacy and safety of Toujeo in more than 3,500 adults with type 1 and type 2 diabetes. All studies in the program successfully met the primary endpoints, demonstrating similar blood sugar control with Toujeo as compared to Lantus.The most common adverse events included nasopharyngitis (12.8% in type 1 patients and 7.1% in type 2 patients) and upper respiratory tract infection (9.5% in type 1 patients and 5.7% in type 2 patients).
Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen containing 450 units of Toujeo, which requires one third of the injection volume to deliver the same number of insulin units as compared to the company's Lantus SoloSTAR. Toujeo is currently pending marketing authorization with the EMA and other health authorities around the world.