- (PLX AI) – Bayer submits application in the EU for an extension of the indication of finerenone to include early stages of chronic kidney disease associated with type 2 diabetes.
- • Regulatory submission is based on positive data from the pivotal Phase III FIGARO-DKD study, published in the New England Journal of Medicine, which covers a broad range of disease severities of chronic kidney disease associated with type 2 diabetes
- • Finerenone was recently approved in the EU under the brand name Kerendia for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults, based on the positive results from the Phase III FIDELIO-DKD study
- • Finerenone is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease associated with type 2 diabetes
Quelle: PLX AI