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Once-Daily Basal Insulin Toujeo Wins FDA Nod

Analysts question labeling

The FDA has approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL, Sanofi), a once-daily long-acting basal insulin, to improve glycemic control in adults with type-1 and type-2 diabetes. The product is expected to be available in the U.S. at the beginning of the second quarter, 2015.

The labeling for Toujeo, however, could make marketing difficult, according to a report from Reuters. Analysts have noted that some potential benefits of Toujeo are not mentioned in the label, which also highlights the need for higher doses of the product to achieve the same level of glycemic control provided by Lantus (insulin glargine [rDNA origin] injection, Sanofi).

Toujeo has the same active ingredient as Lantus (insulin glargine), but at three times the concentration and with a design to release the insulin more gradually.

The approval of Toujeo was based on results from the EDITION clinical trial program, which comprised a series of international phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from diverse diabetes populations (type 1 and type 2). In this program, once-daily Toujeo (300 U/mL) was compared with once-daily Lantus (100 U/mL) in open-label, randomized, active-control, parallel-group, treat-to-target studies of up to 26 weeks’ duration with a 6-month safety extension.

All of the studies in the EDITION program successfully met their primary endpoints by demonstrating similar blood sugar control with Toujeo compared with Lantus. The most common adverse events (excluding hypoglycemia) reported for Toujeo included nasopharyngitis (13% in type-1 patients and 7% in type-2 patients) and upper respiratory tract infections (10% in type-1 patients and 6% in type-2 patients).

Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen that contains 450 units of Toujeo. This pen requires one-third of the injection volume to deliver the same number of insulin units compared with the Lantus SoloSTAR. The maximum single-injection dose of 80 IU meets the needs of most patients requiring basal insulin in the U.S.

More than 370 million people worldwide have diabetes, according to the International Diabetes Federation. As many as 95% have type-2 disease, which is often associated with obesity and can increase the risk of serious health problems.

Sources: Sanofi; February 25, 2015; and Reuters; February 26, 2015.


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