The European Union has given the nod to a new formulation of insulin glargine (Toujeo, Sanofi), which is a higher-strength insulin (300 units/mL) than the existing insulin glargine product on the market (100 units/mL); the latter was first authorized in the European Union as Lantus and Optisulin (both Sanofi) in June 2000.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued its positive opinion on Toujeo for the treatment of adults with type 1 and type 2 diabetes just a day after the US FDA approved the product for the same indication.
As well as containing three times the concentration of insulin glargine, Toujeo is designed to release the insulin more gradually; thus, the product has been labeled an ultralong-acting insulin (U300), or "a next-generation insulin," as Sanofi is calling it.
When Lantus was first launched, it was marketed as a "24-hour-insulin," but, with a half-life of 12 hours, insulin glargine always struggled to live up to that promise and has found itself eclipsed by the long-acting insulin degludec (Tresiba, Novo Nordisk), which has been available in the European Union since January 2013. Insulin degludec is not approved in the United States, however.
Another extremely long-acting basal insulin, peglispro, has just suffered a setback; its manufacturer, Lilly, has said it will have to postpone the marketing application by at least 2 years to evaluate why some patients developed excess liver fat in late-stage studies.
Toujeo Likely Available Within EU Within 2 Months
EU approval is normally a formality 2 months after a positive CHMP opinion, and Sanofi says once approved, its new product will be available in the Toujeo SoloSTAR, a disposable prefilled pen that contains 450 insulin units (IU) and has a maximum single injection dose of 80 IU.
The CHMP decision is based on results from the EDITION clinical-trial program, a worldwide series of phase 3 studies evaluating the efficacy and safety of Toujeo compared with Lantus in more than 3500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy, the company notes in a statement.
Toujeo demonstrated effective blood glucose control, with a favorable safety profile, and significantly lowered hypoglycemic risk in people with type 2 diabetes compared with Lantus, it says.
The company is banking on many patients switching from Lantus to Toujeo ahead of the release of generic insulin glargine.
But it isn't clear whether Toujeo really will be considered as a clinical advance on Lantus, currently the world's most prescribed insulin, with sales of $7.2 billion in 2014.
For example, US analysts have noted that the lower rates of hypoglycemia documented in the studies comparing Toujeo and Lantus is not mentioned on the FDA-approved label.
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Cite this: EU Gives Green Light to Toujeo, a Better Insulin Glargine? - Medscape - Feb 27, 2015.