Tujeo: Exciting New Insulin Primed to Hit Market


 Finally, a new basal insulin has been approved for adults living with type 1 and type 2 diabetes.  For those of you who have been following the news, the much-hyped long-acting insulin Degludec failed to receive U.S. Food and Drug Administration (FDA) approval after the administration requested additional trials looking into cardiovascular outcomes. While the inhaled insulin, Afrezza, recently hit the market, this insulin is designed to take the place of short-acting rather than long-acting or “basal” insulins.

The long-awaited insulin called “Toujeo” was just FDA approved on February 25, 2015.  It is expected to hit the market in April or May of 2015. Although it contains the same active ingredient as Lantus, namely glargine, the concentration of glargine is three times higher in Toujeo versus Lantus. Whereas Lantus contains glargine at a concentration of 100 units per milliliter, Toujeo contains 300 units per milliliter. What this means is that Toujeo requires one third of the injection volume to deliver the same number of insulin units when compared to Lantus. As a result, the new Toujeo SoloSTAR® pens contain 450 units of glargine, whereas the Lantus SoloSTAR® pens contain only 300 units of glargine. In addition, the glargine insulin in Toujeo is designed to be released more slowly into the circulatory system.

The approval of this insulin was based on the FDA review of multiple international studies which looked at the efficacy and safety of Toujeo in over 3,500 adults with both type 1 and type 2 diabetes. All studies reviewed showed that Toujeo led to a similar hemoglobin A1C reduction when compared to Lantus over a 26 week study period. In addition, in three trials of Toujeo, patients using this type of insulin had 31% fewer hypoglycemic episodes overall when compared to Lantus. A fourth trial included 549 patients with type 1 diabetes and showed that the patients taking Toujeo had 30% fewer nocturnal hypoglycemic events when compared to Lantus.

So why the sudden push for a new type of insulin?

Sanofi’s best-selling Lantus, which amassed $7.2 billion of revenues in 2014 alone, lost its patent protection last month. Both Merck and Eli Lilly are set to introduce similar basal insulins to compete with Lantus, and there is pressure for Lantus to decrease its price tag.

Sanofi hopes to convert former Lantus patients to Toujeo. In addition, there are approximately one million new patients starting basal insulin each year who could potentially benefit from Toujeo.

It remains to be seen if Toujeo will be a panacea for patients struggling with diabetes or simply another “me-too” drug. Drawbacks include a five day lag period before the glucose lowering effects are optimized per dose as well as a ~ 10% incidence of upper respiratory infections and inflammation of the throat and nasal passages.


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