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2022 | HFSA

Bayer to Highlight New Cardiovascular and Renal Data at ACC.22, Including Late-Breaking Presentations for KERENDIA® (finerenone) as Well as Oral Factor XIa Inhibitor (asundexian) Program

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WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer will present a range of new clinical data at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22), being held April 2-4, 2022, in Washington, D.C. Data from KERENDIA® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA)1 and asundexian, an investigational oral Factor XIa inhibitor2 will be presented at the meeting. These data highlight Bayer’s ongoing commitment to patients with cardiovascular (CV) and kidney diseases.

Finerenone FIDELITY Prespecified Pooled Analysis Data

New data from FIDELITY, which explored the impact of finerenone on CV and kidney outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), with and without history of CV disease, will be presented within the following late-breaking, live-streamed session:

  • Finerenone and Cardiorenal Outcomes by History of Cardiovascular Disease in Patients With Type 2 Diabetes and Chronic Kidney Disease: FIDELITY Analyses3
    • Session 411 – Featured Clinical Research III
    • April 4, 2022, 1:00-1:10 p.m. (EDT)

The FIDELITY prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD combines the trial populations of patients with CKD (stages 1-4) associated with T2D.

Additional Finerenone Study Data

Also being presented is a new subgroup analysis of FIGARO-DKD and FIDELIO-DKD, investigating finerenone in relation to the population of the United States eligible for the treatment. These data will be shared during the following digital eAbstracts session:

  • Generalizability of FIGARO-DKD And FIDELIO-DKD Trial Criteria to the United States Population Eligible for Finerenone4
    • Session 1187 – Prevention and Health Promotion: Diabetes and Cardiometabolic Disease Digital Presentations
    • April 2, 2022, 8:30 a.m. (EDT)

KERENDIA® (finerenone) was approved on July 9, 2021 based on the results of the FIDELIO-DKD trial to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with T2D.1 The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.1 For more information, see “Important Safety Information” below.