Bayer has submitted a New Drug Application for the mineralocorticoid receptor antagonist.
Bayer has released new cardiovascular outcomes from a phase 3 trial testing finerenone as an addition to standard of care treatment in patients with chronic kidney disease and type 2 diabetes.
The company announced researchers have met the primary endpoint in the FIGARO-DKD study showing finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular death or non-fatal cardiovascular events including myocardial infarction, stroke, or hospitalization for heart failure.
Finerenone is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). The treatment has shown promise in reducing the harmful effects of mineralocorticoid receptor (MR) overactivation, a known driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.
In comparison to the FIDELIO-DKD trial—also a phase 3 study testing finerenone in this patient population, the FIGARO-DKD study included a higher proportion of patients with earlier stage chronic kidney disease and type 2 diabetes.
In the randomized, double-blind, placebo-controlled, parallel-group, event-driven study, 7400 patients with chronic kidney disease and type 2 diabetes across a broad range of disease severity were randomized to receive either finerenone or placebo across more than 1000 sites in 47 countries. Patients received either finerenone 10 mg or 20 mg orally once daily or placebo in addition to the standard of care treatment of blood glucose lowering therapies and maximum tolerated dose of the guideline directed therapies angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs).
“Up to 40 percent of people with type 2 diabetes develop chronic kidney disease, and they are at high risk of experiencing cardiovascular events, as well as progressing to kidney failure,”said Prof. Luis M. Ruilope, Professor at the Public Health and Preventative Medicine department of the Autonoma University and co-principal investigator of the FIGARO-DKD trial, in a statement. “The FIGARO-DKD study delivers important insights into the potential effects on cardiovascular outcomes of finerenone in the management of people with chronic kidney disease and type 2 diabetes.”
Bayer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) based on the data from the Fidelio-DKD study, which was presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020. The data from the FIGARO-DKD study will be presented during an upcoming scientific meeting.
The FDA granted Fast Track designation for the treatment in 2015.