FDA approves Sanofi's diabetes drug Toujeo

The U.S. Food and Drug Administration has approved Sanofi's diabetes drug Toujeo (insulin glargine injection, 300 U/mL). The drug is a once-daily long-acting basal insulin indicated to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of second quarter of 2015.

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 III studies evaluating the efficacy and safety of Toujeo in more than 3,500 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 Sanofi's once-daily Lantus (insulin glargine injection, 100 U/mL).

Lantus, the most prescribed insulin drug in the world, is scheduled to lose patient protection this month, and is the subject of a legal battle between Sanofi and Eli Lilly. http://www.fiercebiotech.com/story/sanofi-blocks-eli-lillys-biosimilar-lantus-goal-line-buys-time/2014-01-31

"Nearly 50% of people living with diabetes remain uncontrolled,"said John Anderson, MD, internal medicine and diabetes specialist, Frist Clinic of Nashville, 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."

All studies of the EDITION program successfully met the primary study endpoints by demonstrating similar blood sugar control with Toujeo as compared to Lantus.The most common adverse events (excluding hypoglycemia) reported for Toujeo 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).