U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review

• KERENDIA^® (finerenone), a non-steroidal mineralocorticoid receptor antagonist (MRA), is the only MRA approved by the U.S. Food and Drug Administration (FDA) for adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40% ¹
• By demonstrating a significant reduction in cardiovascular (CV) death, hospitalization for HF, and urgent HF visits, ¹ KERENDIA is now a core pillar of treatment for patients with HF with LVEF ≥40%
• This FDA approval marks a significant milestone in treatment for the approximately 3.7 million adults in the U.S. with HF with LVEF ≥40%, a population at high risk of hospitalization for heart failure and CV death, even with guideline-directed medical treatment ²

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) approved KERENDIA^® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, ¹ following the agency’s Priority Review of its supplemental New Drug Application (sNDA).

Even with guideline-directed medical treatment, the approximately 3.7 million adults in the U.S. with HF with LVEF ≥40%, also known as mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF), face high rates of hospitalization for HF, impacting survival and placing considerable strain on healthcare systems. ² Each hospitalization is associated with a more than two-fold increase in patients’ risk of cardiovascular (CV) death. ³

The approval was based on results from the Phase III FINEARTS-HF trial, which showed that, on top of standard of care, KERENDIA achieved a 16% relative risk reduction of the composite primary endpoint of CV death and total HF events, defined as hospitalization for HF or an urgent HF visit, compared to placebo on top of standard of care (RR=0.84, 95% CI: 0.74-0.95, p=0.007). 1 The treatment effect was consistent across all prespecified subgroups including with or without SGLT2i use. ¹

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys, ^1,4,5 taking aim at HF with LVEF ≥40% from a different angle. ¹

The overall safety profile of KERENDIA was consistent across all studied indications. ¹ From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), hyponatremia (1.9% vs 0.9%), ⁶ and events related to worsening renal function (18% vs 12%). ¹

Detailed results from the Phase III FINEARTS-HF trial were published in the New England Journal of Medicine.⁷

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – a large and growing group of patients with a poor prognosis,” said Scott D. Solomon, MD, Professor of Medicine, Harvard Medical School, Director, Clinical Trials Outcomes Center, Mass General Brigham, and Chair of the Executive Committee for the FINEARTS-HF study. “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”

“People with heart failure with left ventricular ejection fraction ≥40% face the very real possibilities of hospitalization for heart failure or CV death due to their disease,” ^2,3 said Alanna Morris-Simon, MD, MSc, Senior Medical Director of U.S. Medical Affairs at Bayer. “Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or CV death, ⁸ and 25% who experience hospitalization are readmitted due to heart failure within one year of discharge. ⁹ Now, as a core pillar of treatment, KERENDIA can help patients reduce these risks.”

Since July 2021, KERENDIA has been approved to reduce the risk of CV death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). ¹ This new indication expands KERENDIA’s established cardiovascular benefit to a new patient population not limited to CKD associated with T2D—adult patients with HF with LVEF ≥40%. ¹

About FINEARTS-HF ¹⁰
The FINEARTS-HF trial, a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III trial evaluated the efficacy and safety of KERENDIA for the reduction of risk of CV death and total HF events in patients with a diagnosis of symptomatic HF (New York Heart Association class II-IV) with an LVEF ≥40%, measured by local imaging within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of CV death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Approximately 6,000 participants were randomized to receive either KERENDIA or placebo once daily for up to 42 months in addition to their background HF therapies.

The FINEARTS-HF trial is part of KERENDIA’s MOONRAKER program, which is expected to be one of the largest HF study programs to date. With more than 15,000 patients worldwide, MOONRAKER aims to establish a comprehensive body of evidence for KERENDIA across a broad spectrum of patients and clinical settings. ¹¹

About KERENDIA’s Clinical Trial Program
KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF, ¹² CONFIRMATION-HF ¹³ and FINALITY-HF. ¹⁴ The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD as well as the ongoing investigational studies FIND-CKD, ¹⁵ FIONA, ¹⁶ FIONA-OLE, ¹⁷ and FINE-ONE. ¹⁸

About KERENDIA^® (finerenone) ¹

INDICATIONS:
KERENDIA (finerenone) is indicated to reduce the risk of:

• sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
• cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

IMPORTANT SAFETY INFORMATION ¹

CONTRAINDICATIONS:

• Hypersensitivity to any component of this product ¹
• Concomitant use with strong CYP3A4 inhibitors ¹
• Patients with adrenal insufficiency ¹

WARNINGS AND PRECAUTIONS:

• Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. ¹
  
  Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium. ¹
  

• Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed. ¹
  
  Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m² is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function. ¹

MOST COMMON ADVERSE REACTIONS:

• CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%). ¹
• HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). ⁶ Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%). ¹

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice. ¹
• Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate. ¹
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers. ¹
• Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions. ¹

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment. ¹
• Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B). ¹

Please see the Prescribing Information for KERENDIA.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Media:
Elaine Colón
Bayer Media Relations
elaine.colon@bayer.com
+1-732-236-1587