Bayer's finerenone has hit key targets in a late-stage trial assessing its safety and efficacy in patients with chronic kidney disease (CKD) and type 2 diabetes.
Data from the Phase III FIDELIO-DKD renal outcomes study show that the drug significantly reduced the combined primary endpoint of chronic kidney disease progression, kidney failure or kidney death versus placebo when added to standard of care.
Finerenone also lowered the risk of a composite of time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalisation, thereby by also meeting secondary targets.
Finerenone is the first investigational non-steroidal, selective mineralocorticoid receptor antagonist to show renal and cardiovascular benefits in patients with chronic kidney disease and type 2 diabetes, according to the firm.
Bayer said it will discuss the data with health authorities with a view to submitting a marketing application in this setting.