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Bayer's Finerenone Meets Primary Endpoint In Phase III Cardiovascular Study

Bayer's (BAYZF.PK,BAYRY.PK,BYR.L) phase III study FIGARO-DKD, which evaluated the efficacy and safety of the investigational drug finerenone versus placebo when added to standard of care in patients with chronic kidney disease or CKD and type 2 diabetes or T2D, has met its primary endpoint.

The study results showed that finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular or CV death or non-fatal CV events (myocardial infarction, stroke, or heart failure hospitalization).

Compared to FIDELIO-DKD, the first of the two Phase III studies investigating finerenone in patients with CKD and T2D, FIGARO-DKD included more patients with earlier stage CKD and T2D.

FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven Phase III study investigating finerenone versus placebo in patients with CKD and T2D. The study included approximately 7,400 patients from more than 1,000 sites across 47 countries worldwide.

Patients were randomized to receive either finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of RAS-blocking therapy such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).

Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 patients with symptomatic heart failure with a left ventricular ejection fraction of =40%.

The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total heart failure events.

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