Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo®

Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Toujeo^® (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, 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 Q2 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 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.

“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.”

All studies of the EDITION program successfully met the primary study endpoints by demonstrating similar blood sugar control with Toujeo as compared to Lantus.^1,2 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).

Toujeo’s Pharmacokinetic/Pharmacodynamic (PK/PD) information and its rates of severe and documented symptomatic hypoglycemia can be found in the label.

Toujeo 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 the same number of insulin units as compared to the Lantus SoloSTAR^®. The maximum single injection dose of 80 IU meets the needs of the vast majority of patients on basal insulin in the U.S., who require 80 IU or less per day. Toujeo is currently pending marketing authorization with the European Medicines Agency (EMA) and other health authorities around the world.

About Toujeo
Prescription Toujeo is a long-acting insulin used to treat adults with type 2 and type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

About Lantus
Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and patients (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris and in New York.

Reference: 1. Press Release of Sanofi dated February, 25th, 2015.