CHMP issues positive opinion to extend Invokana® (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes.

Cambridge, 29 th May 2020 – Mundipharma welcomes the news that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to extend the indication of Invokana ® (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial. If approved by the European Commission, canagliflozin would be the only SGLT2i with an indication extension to treat diabetic kidney disease (DKD) in European T2DM patients.