Sanofi, the global healthcare leader has core strengths in the field of healthcare due to its seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. This article will focus on Sanofi Diabetes. In August 2014, our previous article “Sanofi buys Mannkind’s inhaled insulin for €824.5m” suggested that Sanofi may launch the first ever inhaled insulin in 2015. It’s now done! The U.S. Food and Drug Administration (FDA) approved Toujeo, a long-acting basal insulin patients have to inhale only once a day, enabling type 1 and type 2 diabetes sufferes to control their glycemic level .
John Anderson, MD, internal medicine and diabetes specialist, Frist Clinic of Nashville, TN, and Past President of the American Diabetes Association, said:“Nearly 50 percent of people living with diabetes remain uncontrolled. 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.”
The approval of Toujeo was based on the FDA’s review of the results of the EDITION clinical trial program, which comprised a series of international Phase III studies evaluating the efficacy and safety of Toujeo over more than 3,500 adults from broad and diverse diabetes populations (type 1 and type 2). All studies of the EDITION program successfully met the primary study endpoints by demonstrating similar blood sugar control with Toujeo as compared to Lantus.
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. It should be available during Q2 2015 in the U.S..
Pierre Chancel, Senior VP, Global Diabetes at Sanofi stated: “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”