Posted by Michael Wonder on 05 Jul 2020
European Commission approves extended Invokana (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes seen in CREDENCE study
1 July 2020 - The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Phase III renal outcomes trial, which was stopped early after a planned interim analysis based on the achievement of a pre-specified efficacy criterion.
Mundipharma today announces that the European Commission has approved the extension of 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.
Canagliflozin is now the only sodium glucose co-transporter 2 inhibitor approved in Europe with an extended indication to treat diabetic kidney disease in type 2 diabetes patients.
