New, more potent diabetes drug approved by FDA

February 27, 2015

FDA has approved a new once-daily, long-acting basal insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL, Sanofi) for the treatment of adults with type 1 and type 2 diabetes mellitus. It is described as a more potent follow-up to the manufacturer’s insulin product Lantus (insulin glargine [rDNA origin] injection, 100 U/mL).

FDA has approved a new once-daily, long-acting basal insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL, Sanofi) for the treatment of adults with type 1 and type 2 diabetes mellitus. It is described as a more potent follow-up to the manufacturer’s insulin product Lantus (insulin glargine [rDNA origin] injection, 100 U/mL).

As the older drug is soon to lose its patent protection in the United States, it is anticipated that the manufacturer will seek to convert patients to the new basil insulin drug as soon as possible. While the active ingredient, insulin glargine, is the same for both drugs, the new version includes insulin glargine at 3 times the concentration of the earlier drug. It also has been designed to more gradually release the insulin.

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The use of this new long-acting basal insulin has been found to result in significantly lower rates of hypoglycemia than its predecessor, while providing similar blood glucose control.

FDA's approval was based on the agency’s review of results from the EDITION clinical trial program. It included a series of international phase 3 studies evaluating the efficacy and safety of the new drug in more than 3,500 adults from broad and diverse type 1 and type 2 diabetes populations.

In the clinical trial program, once-daily insulin glargine [rDNA origin] injection, 300 U/mL, was compared to that of once-daily insulin glargine [rDNA origin] injection, 100 U/mL. These open-label, randomized, active-control, parallel, treat-to-target studies continued for up to 26 weeks with a safety extension of 6 months. All studies of the EDITION program successfully met the primary study end points by demonstrating similar blood glucose control with the use of both insulin products.

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Diabetes continues to be a disease of concern internationally, affecting an estimated 370 million individuals worldwide as reported by the International Diabetes Federation. Many patients with type 2 diabetes who start treatment with other medications to control blood glucose levels may ultimately need insulin as the disease progresses.

This new drug is expected to be available for use in the United States at the beginning of the second quarter of 2015.