FDA approves Toujeo (insulin glargine [rDNA origin]) for treatment of Type 1 and Type 2 Diabetes-Sanofi

Sanofi announced that the 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. 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).

Comment:Toujeo (formerly known as U300) is an essential improvement, as an estimated 15–20% of type 1 diabetic patients are currently not well controlled on Lantus. The relatively short half-life of Lantus of around 12 hours can also be a problem for some type 2 diabetic patients, who have to inject twice a day or use supplemental insulin to manage their blood glucose. Toujeo will offer prolonged duration of action and reduced nocturnal hypoglycemia rates. Competition will be Tresiba (insulin degludec) from Novo Nordisk which is EU approved but required to undertake a further trial in the US. A further entrant to the scene is LY 2963016 a biosimilar version of Lantus from Eli Lilly and Boehringer which is filed at the FDA but subject to patent litigation.