FDA Approves New Once-Daily Insulin Product

The US Food and Drug Administration (FDA) has approved Sanofi’s once-daily long-acting basal insulin product Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) for the improvement of glycemic control in adults living with type 1 and type 2 diabetes.

According to the company, “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.”

During clinical trials, the most common adverse events 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).

Sanofi reports that 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 should not be used to treat diabetic ketoacidosis. Toujeo should also not be used by patients during episodes of low blood sugar. The most common side effect of Toujeo (and other insulin products) is hypoglycemia.