Tag: Toujeo

The European Commission has granted Sanofi marketing authorization in Europe for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), for the treatment of type 1 and type 2 diabetes mellitus in adults. Toujeo is a next-generation, once-daily basal insulin based on a broadly-used molecule (insulin glargine) with a well-established benefit-risk profile.

The U.S. Food and Drug Administration (FDA) approved Sanofi’s new once daily long acting insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) for treatment of adults living with type 1 and type 2 diabetes. Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 units of Toujeo and requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus SoloSTAR.

The U.S. Food and Drug Administration (FDA) has accepted for review Sanofi’s New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27, 2014.