New Sanofi drug Toujeo given FDA approval

Thu, 26 Feb 2015
Sanofi's diabetes drug Toujeo has been given approval by the US Food and Drug Administration (FDA) to improve glycemic control in people with type 1 and type 2 diabetes.

Toujeo is a once-daily, long-acting basal insulin and follows up from Lantus, the French pharmaceutical company's top selling insulin product.

FDA approval was granted following results from the EDITION clinical trial program, in which the safety and efficacy of Toujeo was assessed in over 3,500 adults with type 2 and type 1 diabetes.

All patients demonstrated similar blood sugar control with Toujeo when compared to Lantus. Both drugs have the same active ingredient, called insulin glargine, but the concentration is three times higher in Toujeo.

Sanofi is set to lose US patent protection for Lantus, which could happen later this year, and the company will now be trying to convert Lantus users to Toujeo as a matter of urgency.

Previous studies have showed that patients taking Toujeo experience hypoglycemia less during sleep compared to those taking Lantus.

When will Toujeo be released?

Toujeo is expected to be available in the US at the beginning of their second economic quarter (between April and June), while a price has yet to be announced.

Marketing authorisation is currently pending with the European Medicines Agency so as of yet there is no scheduled release date for Toujeo in the United Kingdom.

Sanofi announced on February 27 that Toujeo has been recommended for approval in Europe. It is expected to be marketed soon in Britain and Germany.
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