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FDA approves Sanofi's Toujeo insulin

Wednesday, March 11 2015 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration approved Sanofi's Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults with type 1 and type 2 diabetes.

The approval was based on the EDITION clinical trial program, a series of international Phase III studies that involved more than 3,500 adult participants with type 1 or type 2 diabetes. The open-label, randomized, parallel, treat-to-target trials lasted up to 26 weeks with a safety extension of 6 months and compared the efficacy and safety of once-daily Toujeo to Sanofi's once-daily Lantus (insulin glargine [rDNA origin] injection, 100 U/mL).

The trials showed similar blood glucose control could be achieved by either drug. The most common adverse events (excluding hypoglycemia) reported for Toujeo included nasopharyngitis (12.8% in patients with type 1 diabetes and 7.1% in those with type 2 diabetes) and upper respiratory tract infection (9.5% in patients with type 1 diabetes and 5.7% in patients with type 2 diabetes).

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

Toujeo is pending marketing authorization with the European Medicines Agency and other health authorities around the world.

The drug is expected to be available in the U.S. at the beginning of the second quarter of 2015.

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