NAPSR News: Sanofi receives FDA approval for once-daily basal insulin Toujeo

WASHINGTON - Feb. 26, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, intended to improve the glycemic index in adults living with type 1 and type 2 diabetes. "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.

Approval was based on results achieved from the EDITION clinical trial program- a series s of international Phase III studies assessing the efficacy and safety of Toujeo in over  3,500 adults from various diabetes populations (type 1 and type 2). "Nearly 50 percent of people living with diabetes remain uncontrolled," said John Anderson, MD, internal medicine and diabetes specialist, Frist Clinic of Nashville, TN, and Past President of the American Diabetes Association. "Despite the proven efficacy of insulin, ensuring effective titration and maintenance can be a challenge for both patients and healthcare professionals due to hypoglycemia concerns. Toujeo provides a new option that may help patients manage their diabetes." According to the clinical trial, Toujeo demonstrated similar blood sugar control in comparison to once-daily Lantus (insulin glargine [rDNA origin] injection 100 U/mL).

Toujeo is expected to be launched in the U.S. at the beginning of  the second quarter in 2015 and will be available in the Toujeo SoloSTAR®, a disposable prefilled pen which contains 450 units of Toujeo and requires one third of the injection volume to deliver insulin units.

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