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Bayer’s finerenone scores FDA priority review for chronic kidney disease

FDA priority review is based on data from the phase 3 FIDELIO-DKD trial

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.

“Based on study data, finerenone offers a potential new strategy to delay CKD progression, while reducing the risk of cardiovascular events,” said Michael Devoy, head of medical affairs & pharmacovigilance of Bayer’s Pharmaceuticals Division and chief medical officer.

“We’re encouraged that the FDA has granted the new drug application a priority review, as it potentially expedites our ability to make finerenone available to patients,” he added.

In September 2020, AstraZeneca announced that its SGLT2 inhibitor Farxiga (dapagliflozin) plus standard of care reduced the risk of cardiovascular or renal death and worsening of renal function by 39% compared to placebo in patients with CKD.

The results were consistent in patients both with and without type 2 diabetes, opening up the potential market for the SGLT2 inhibitor if it wins approval in this indication. The trial also met all key secondary endpoints, including significantly reducing death from any cause by 31% compared to placebo.

Earlier this year, Farxiga also won a priority review from the FDA, with a decision on the new drug application (NDA) expected in the second quarter of 2021.

Although Bayer did not reveal the exact target action date for the FDA’s decision on finerenone, it said in a statement that the agency aims to ‘take action’ on a NDA within six months of acceptance, setting up a potential decision in July.

Article by
Lucy Parsons

14th January 2021

From: Regulatory



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