Sanofi receives CHMP recommendation for Toujeo approval

Sanofi has announced that Toujeo, its next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes, has been recommended for European approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the drug for approval based on positive data from the phase III Edition clinical trial programme, which involved more than 3,500 patients.

Toujeo has demonstrated effective blood sugar control, with a favourable safety profile, and can significantly lower hypoglycaemic risk in people with type 2 diabetes at any time of the day, compared to its predecessor Lantus.

Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen that contains 450 insulin units.

Pierre Chancel, senior vice-president for global diabetes at Sanofi, said: "Today's CHMP opinion is another step forward to make Toujeo available to people living with diabetes who are currently not at their glycaemic target, or are about to start insulin therapy."

Sanofi's diabetes business was one of its key drivers of growth in 2014, helping it to achieve a 4.9 percent year-on-year sales increase during the period.