Sanofi Updates Lantus Label in EU, ORIGIN Results on Lantus® Cardiovascular Safety Integrated Into European Union Product Label

Lantus® (insulin glargine)

Sanofi  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.

MECHANISM OF ACTION
Insulin glargine (lantus) mechanism of action.

LANTUS (insulin glargine rdna origin injection) consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine rdna origin injection) contains 100 IU (3.6378 mg) insulin glargine.

LANTUS® is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent.,  LANTUS (insulin glargine rdna origin injection) is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acidasparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063.