FDA Approves New Basal Insulin

Sanofi has announced the FDA approval of its insulin glargine (rDNA origin) injection (Toujeo), a once-daily long-acting basal insulin, for the improvement of glycemic control in adults with type 1 and type 2 diabetes.

The FDA based its nod on the results from several international phase 3 studies evaluating Toujeo’s safety and efficacy in more than 3500 diabetic patients. The research team found that patients treated with Toujeo experienced comparable levels of blood sugar control as those who were given Sanofi’s insulin glargine (rDNA origin) injection (Lantus).

“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,” said Pierre Chancel, senior vice president of Global Diabetes at Sanofi, in a press release. “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.”

“Nearly 50% of people living with diabetes remain uncontrolled,” added John Anderson, MD, internal medicine and diabetes specialist at Frist Clinic of Nashville, Tennessee 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.”

Excluding hypoglycemia, a side effect frequently associated with the use of insulin, the most common adverse events reported by Toujeo-treated trial participants included nasopharyngitis and upper respiratory tract infection.

Toujeo will be available as Toujeo Solostar, a disposable prefilled pen containing 450 units of insulin.

Sanofi plans to launch Toujeo in the United States by the beginning of the second quarter of 2015, according to a manufacturer press release.