Posted by Michael Wonder on 22 Aug 2019
Mundipharma announces the licence extension submission for Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) to the European Medicines Agency
22 August 2019 - The CREDENCE renal outcomes study, which was stopped early due to positive efficacy findings, served as the basis for the licence extension submission.
As the European distributor of Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin), Mundipharma welcomes the news that the EMA has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus.
The submission is based on the results from the landmark Phase III CREDENCE study which evaluated the efficacy and safety of canagliflozin versus placebo in this high-risk patient population when used in addition to standard of care.
