Breakthrough Clinical Results
The U.S. Food and Drug Administration (FDA) has approved KERENDIA® (finerenone) to treat heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%. This non-steroidal mineralocorticoid receptor antagonist (MRA) demonstrated a significant reduction in cardiovascular (CV) death, HF hospitalization, and urgent HF visits in the Phase III FINEARTS-HF trial. The approval expands treatment options for approximately 3.7 million adults in the U.S. with this condition, who remain at high risk even with guideline-directed medical therapy. KERENDIA selectively blocks mineralocorticoid receptor overactivation in the heart and kidneys. While the drug has a generally consistent safety profile across indications, hyperkalemia, hypotension, hyponatremia, and worsening renal function were reported more frequently than placebo in the FINEARTS-HF trial. This approval adds to KERENDIA's existing indication for chronic kidney disease associated with type 2 diabetes.
Key Highlights
- FDA approves KERENDIA® (finerenone) for heart failure (HF) with LVEF ≥40%
- KERENDIA® significantly reduces cardiovascular death, HF hospitalization, and urgent HF visits
- Approval expands treatment options for approximately 3.7 million adults in the U.S.
- KERENDIA® is a non-steroidal mineralocorticoid receptor antagonist (nsMRA)
Incidence and Prevalence
Heart Failure: Global Incidence and Prevalence Estimates
Heart failure represents a major and growing public health concern in most affluent countries, primarily due to aging populations and the prolongation of cardiac patients' lives through modern therapy.
Prevalence Data
European Studies
A German study from 2013 provided comprehensive prevalence data, finding that the overall age-standardized prevalence of symptomatic chronic heart failure (CHF) was 7.7% (95%CI 6.0-9.8) for men and 9.0% (95%CI 7.0-11.5) for women.
The prevalence of CHF strongly increased with age in the German population: - 3.0% among 45-54-year-old subjects - Rising to 22.0% among 75-83-year-old subjects
In terms of heart failure types, the German study found that among subjects with CHF: - Symptomatic HFREF (heart failure with reduced ejection fraction) was present in 48% of cases - Symptomatic HFNEF (heart failure with normal ejection fraction) accounted for 52% of cases
A Spanish study from 2009 reported a weighted prevalence of congestive heart failure of 6.8% (95% confidence interval 4%-8.7%) in individuals aged 45 years or more. This study found prevalence was similar in men (6.5%, 95% CI 4.7%-8.4%) and women (7%, 95% CI 4.4%-9.6%).
The Spanish study also provided age-stratified prevalence data: - 1.3% (0.4%-2.1%) in those aged 45-54 years - 5.5% (2.4%-8.5%) in those aged 55-64 years - 8% (4.2%-11.8%) in those aged 65-74 years - 16.1% (11%-21.1%) in those aged over 74 years
United States Data
In the United States, older data indicates there are more than 3 million people with cardiac failure (over 1% of the population) with over 400,000 new patients each year.
Incidence Data
The Framingham Study reported that annual incidence of heart failure increased from 3 per 1000 at ages 35-64 years to 10 per 1000 at ages 65-94 years with a male predominance, attributed to higher rates of coronary disease.
Risk Factors and Comorbidities
Persons with CHF were more likely to have hypertension (PR = 3.4; 95%CI 1.6-7.3) or to have had a previous myocardial infarction (PR = 2.5, 95%CI 1.8-3.5).
Hypertension is the dominant precursor of CHF, increasing risk 2-6 fold, with 70% of heart failure patients having antecedent hypertension.
Diabetic nephropathy is also significant, being a leading cause of end-stage renal disease. In the United States, diabetic nephropathy accounts for approximately 40% of patients beginning renal replacement therapy.
Prognosis
Despite modern treatments, CHF continues to be a lethal end-stage of heart disease with a 50% 5-year mortality rate.
The Framingham Study reported median survival of only 1.7 years for men and 3.2 years for women, with only 25% of men and 38% of women surviving 5 years after diagnosis.
Economic Burden
Economic Burden of Heart Failure Treatment
Economic Burden in USA and Europe
The economic burden of treating heart failure remains substantial in both the USA and Europe according to recent evidence. Heart failure represents 1-2% of the total healthcare budget in some healthcare systems, with hospital costs accounting for approximately 70% of this expenditure.
A 2009 study examining resource use and cost of care for patients with advanced heart failure in the USA found that the mean cost of medical management in the final 2 years of life was $156,169, with 50.5% ($78,880) expended in the final 6 months. The mean quarterly cost increased 4.9-fold from $8,816 to $42,836 in the final months of life, while inpatient days increased 6.6-fold from 3.8 days to 22.2 days during the same period.
A 2000 study in the USA found that during the study period, 14% of chronic heart failure (CHF) patients were admitted to the hospital at a cost of almost $3 million (an average of $7,863 per hospitalized patient). This study also found that 78% of the CHF population received prescription drugs, at an average per-patient cost of $942. Hospitalization accounted for 54% of the total cost for CHF treatment, with prescription drugs accounting for 38%.
In Europe, a 2019 study from Catalonia (Spain) analyzed data from 155,883 chronic heart failure (CHF) patients, revealing that lower income was associated with higher mortality and different patterns of healthcare resource utilization. In this Spanish study, patients with lower income levels had their healthcare resource use shifted toward urgent hospitalizations and frequent emergency department visits, rather than regular, specialized CHF ambulatory-based care.
An Irish study from 2001 found that the average cost of a hospital admission for cardiac failure was IR £2,146, with an average cost per day of IR £193. In this Irish study, approximately 75% of hospital costs were associated with ward costs, while medications accounted for only 3.5% of total costs.
Intervention Costs and Effectiveness
A 2012 study comparing home-based intervention (HBI) versus clinic-based intervention (CBI) for CHF patients found that while both had similar rates of hospitalization or death, HBI was associated with significantly lower healthcare costs ($AU3.93 vs. $AU5.53 million). The median duration of unplanned hospitalization was significantly less in the HBI group (4.0 days vs. 6.0 days), resulting in healthcare costs that were significantly less for the HBI group (median: $AU34 per day vs. $AU52 per day).
A 2011 study analyzed costs in 190 congestive heart failure patients and found that per patient costs for heart failure treatment in the usual care group were €7,109 ± 11,687 compared to €2,991 ± 4,885 in the BNC (NT-proBNP-guided) group. When corrected for death as a competing risk, costs in the usual care group were €7,893 ± 11,734 and were reduced by BNC to €3,148 ± 4,949.
Considering all-cause re-hospitalization costs, the calculated costs per year survived after discharge were €19,694 ± 26,754 for usual care, €14,262 ± 25,330 for home-based nurse care, and €8,784 ± 14,728 for BNC. NT-BNP-guided heart failure specialist care in addition to home-based nurse care was found to be cost effective and cheaper than standard care.
A 2010 study of 11,140 patients with type 2 diabetes found that hospital costs for patients with heart failure were significant across different regions, with heart failure being among the most costly complications at more than Int$1,800, Int$3,000, and Int$4,000 in Asia, Eastern Europe, and Established Market Economies respectively.
A 2011 Chinese study found that intensive clinic follow-up for outpatients with CHF reduced hospital costs by 3821.51 RMB per patient compared to usual care. Re-hospitalization is identified as the main contributing economic factor in heart failure expenditures, and intensive outpatient care programs have been shown to reduce inpatient costs while improving outcomes.
Drug used in other indications
Clinical Indications for KERENDIA® (Finerenone) Beyond Heart Failure
Based on the available information, finerenone (KERENDIA®) has been studied in patients with type 2 diabetes mellitus (T2DM) for its effects on cardiovascular and renal outcomes.
Clinical Trial Information
A retrospective cohort analysis was conducted using the TriNetX US Collaborative Network database that examined finerenone in comparison with spironolactone and eplerenone in T2DM patients. This study:
- Included adult patients with T2DM who were newly prescribed finerenone, spironolactone, or eplerenone between 2021-2024
- Applied one-to-one propensity score matching to eligible participants
- Matched 2,957 finerenone users with spironolactone users
- Matched 1,603 finerenone users with eplerenone users
- Assessed cardiovascular outcomes including major adverse cardiovascular events (MACE), heart failure, and mortality over 24 months of follow-up
- Used Cox regression models to calculate hazard ratios (HR) with 95% confidence intervals (CI)
Study Results
The study found that finerenone users had significantly lower rates of MACE compared with: - Spironolactone users (HR: 0.53, 95% CI: 0.43-0.66) - Eplerenone users (HR: 0.66, 95% CI: 0.50-0.87)
This suggests that finerenone may have beneficial effects on cardiovascular outcomes in patients with type 2 diabetes mellitus beyond its applications in heart failure.
The available information does not provide specific details about other non-heart failure indications being investigated for finerenone in Phase 1-4 clinical trials, nor does it mention specific dosing regimens for finerenone in non-heart failure conditions.