June 5, 2013

ORIGIN Results on Lantus® Cardiovascular Safety Integrated Into European Union Product Label

 

ORIGIN Results on Lantus® Cardiovascular Safety Integrated Into European Union Product Label

Paris, France – June 5, 2013 – Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for inclusion in the Lantus® (insulin glargine) product label of safety and efficacy data from the insulin glargine cardiovascular (CV) outcomes trial ORIGIN (Outcome Reduction with Initial Glargine INtervention). The revised label is evidence of Sanofi’s ongoing commitment to further assert the well-known safety and efficacy profile of insulin glargine, the most-studied basal insulin. The indication for the use of Lantus® remains unchanged.