English to Russian Medical Medical: Pharmaceuticals

Volume depletion and Fournier’s gangrene have been added to the list of important potential risks in T1DM and T2DM **based upon being a class-effect** and given the description of these events in the approved SmPC

These are not considered new risks.
In summary, the sotagliflozin clinical development program for T'DM has demonstrated the efficacy and safety of the compound in this disease.