EC Approves Extended Invokana Indication On Renal Outcomes In DKD

First SGLT2 Inhibitor In Europe To Gain Extended Indication

Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.    

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Janssen Pharmaceutical Cos./Mundipharma International Corp. Ltd.’s SGLT2 inhibitor, Invokana (canagliflozin), has become the first drug in nearly 20 years to have its indications in Europe extended to include renal outcomes data from a Phase III study in patients with diabetic kidney disease (DKD) and type 2 diabetes.

The European Commission’s approval, announced by Mundipharma on 1 July, follows a positive recommendation from the EMA’s CHMP in May...

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