Bayer’s finerenone scores FDA priority review for chronic kidney disease
Bayer has scored a US Food and Drug Administration (FDA) priority review for its investigational drug finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
Finerenone – also known as BAY 94-8862 – is a selective mineralocorticoid receptor antagonist (MRA). Overactivation of the mineralocorticoid receptor is believed to play a key role in kidney and cardiovascular damage, through inflammatory and fibrotic processes.
The FDA submission is based on data from the phase 3 FIDELIO-DKD trial, which evaluated finerenone in patients with CKD and T2D. The participants were randomly assigned in a 1:1 ratio to receive either Bayer’s investigational drug or a placebo.
In this trial, patients with CKD and T2D who received finerenone treatment experienced lower risks of CKD progression and cardiovascular events compared to placebo.
On the primary endpoint of kidney failure outcomes, patients treated with finerenone an 18% relative risk reduction compared to the placebo group.
The key secondary endpoint, which measures cardiovascular outcomes, found that the finerenone treatment group had a relative risk reduction of 14% compared to the placebo group.
Read more: http://www.pmlive.com/pharma_news/bayers_finerenone_scores_fda_priority_review_for_chronic_kidney_disease_1361314
Finerenone – also known as BAY 94-8862 – is a selective mineralocorticoid receptor antagonist (MRA). Overactivation of the mineralocorticoid receptor is believed to play a key role in kidney and cardiovascular damage, through inflammatory and fibrotic processes.
The FDA submission is based on data from the phase 3 FIDELIO-DKD trial, which evaluated finerenone in patients with CKD and T2D. The participants were randomly assigned in a 1:1 ratio to receive either Bayer’s investigational drug or a placebo.
In this trial, patients with CKD and T2D who received finerenone treatment experienced lower risks of CKD progression and cardiovascular events compared to placebo.
On the primary endpoint of kidney failure outcomes, patients treated with finerenone an 18% relative risk reduction compared to the placebo group.
The key secondary endpoint, which measures cardiovascular outcomes, found that the finerenone treatment group had a relative risk reduction of 14% compared to the placebo group.
Read more: http://www.pmlive.com/pharma_news/bayers_finerenone_scores_fda_priority_review_for_chronic_kidney_disease_1361314