- FINEARTS-HF met its primary endpoint,1 achieving a
statistically significant reduction of the composite of
cardiovascular death and total (first and recurrent) heart failure
(HF) events, defined as hospitalizations for HF or urgent HF visits
2
- KERENDIA is the first non-steroidal, selective
mineralocorticoid receptor antagonist (MRA) to meet a primary
cardiovascular endpoint in a Phase III study investigating patients
with HF with mildly reduced or preserved ejection fraction
(LVEF>40%) 1
- KERENDIA already has established cardiovascular benefit
(reduction in hospitalization for HF, CV death and non-fatal MI) in
adults with chronic kidney disease (CKD) in type 2 diabetes (T2D)3,
and this new topline data provides positive results in a different
patient population not limited to CKD in T2D— patients diagnosed
with HF (LVEF>40) 1
- The clinical data from FINEARTS-HF will be presented at the
European Society of Cardiology (ESC) Congress 2024
- Bayer plans to discuss the data and submission for regulatory
approval with the U.S. Food and Drug Administration (FDA)
Bayer announced today that FINEARTS-HF met its primary
endpoint,1 achieving a statistically significant reduction of the
composite of cardiovascular death and total (first and recurrent)
heart failure (HF) events, defined as hospitalizations for HF or
urgent HF visits. The randomized, double-blind, placebo-controlled,
parallel-group, multi-center phase III cardiovascular outcomes
study evaluated the efficacy and safety of KERENDIA® (finerenone)
for investigational new use in patients with HF with a LVEF≥40%2
(left ventricular ejection fraction), a measurement that indicates
how much blood the left ventricle of the heart pumps with each
beat.4 In the FINEARTS-HF trial, no new safety signals were
identified compared with those seen in previous studies with the
compound.1
KERENDIA is approved to reduce the risk of cardiovascular death,
non-fatal myocardial infarction, hospitalization for heart failure,
sustained eGFR decline, and end-stage kidney disease in adult
patients with CKD associated with T2D. 3
KERENDIA is a non-steroidal, selective mineralocorticoid
receptor antagonist (MRA) with established cardiovascular benefit
(reduction in hospitalization for HF, CV death and non-fatal MI) in
adults with CKD in T2D,3 and this new topline data provides
positive results in a different patient population not limited to
CKD in T2D— patients diagnosed with HF (LVEF>40).1
Bayer will present the FINEARTS-HF data at the European Society
of Cardiology (ESC) Congress 2024 in September and plans to discuss
submission for regulatory approval with the U.S. Food and Drug
Administration (FDA).
The FINEARTS-HF study 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 in total and aims to establish
a comprehensive understanding of KERENDIA in HF across a broad
spectrum of patients and clinical settings.1
Heart failure is a complex clinical syndrome with symptoms and
signs that result from any structural or functional impairment of
ventricular filling or ejection of blood.5 Approximately 6.7
million adults in the U.S. suffer from HF, with about 55% having an
LVEF ≥ 40%.6 Despite the high prevalence, guideline-directed
medical treatment options for patients with HF with LVEF ≥ 40% are
limited.7 This patient group is often balancing multiple
comorbidities like obesity, hypertension and chronic kidney disease
(CKD), adding additional considerations for physicians when
considering treatment.5
“Bayer is determined to drive research and innovations that have
the potential to become treatment options for diseases with high
unmet medical need, including for patients with mildly reduced or
preserved ejection fraction,” said Dr. Christian Rommel, Head of
Research and Development at Bayer’s Pharmaceuticals Division.
About FINEARTS-HF2
FINEARTS-HF is a randomized, double-blind, placebo-controlled,
multicenter, event-driven phase III study investigating the
efficacy and safety of KERENDIA (finerenone) for the reduction of
risk of cardiovascular death and heart failure (HF) events in
patients with a diagnosis of symptomatic heart failure (New York
Heart Association class II-IV) with a left ventricular ejection
fraction (LVEF) of ≥40%, measured by local imaging measurement
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 cardiovascular death and total
(first and recurrent) HF events, defined as hospitalizations for HF
or urgent HF visits.
Approximately 6,000 patients were randomized to receive either
finerenone or placebo once daily for up to 42 months.2
With overall more than 15,000 patients, the MOONRAKER clinical
trial program with finerenone, including FINEARTS-HF, is one of the
largest HF study programs to date, and aims to establish a
comprehensive body of evidence for finerenone across a broad
spectrum of patients and clinical settings.1
About KERENDIA® (finerenone)3
KERENDIA is a non-steroidal mineralocorticoid receptor
antagonist (MRA) and was approved by the U.S. Food and Drug
Administration (FDA) in July 2021 to reduce the risk of sustained
eGFR decline, end-stage kidney disease, cardiovascular death,
non-fatal myocardial infarction, and hospitalization for heart
failure in adults with CKD associated with T2D.
In adults with CKD associated with T2D, KERENDIA has been
recommended to reduce the risk of hospitalization for heart failure
by the American Diabetes Association (ADA) 8 and European Society
of Cardiology (ESC).9
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- Concomitant use with strong CYP3A4 inhibitors
- Patients with adrenal insufficiency
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. 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 >5.0 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.
MOST COMMON ADVERSE REACTIONS:
- From the pooled data of 2 placebo-controlled studies, the
adverse reactions reported in ≥1% of patients on KERENDIA and more
frequently than placebo were hyperkalemia (14% versus 6.9%),
hypotension (4.6% versus 3.9%), and hyponatremia (1.3% versus
0.7%).
DRUG INTERACTIONS:
- Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA
with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant
intake of grapefruit or grapefruit juice.
- 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.
- Strong and Moderate CYP3A4 Inducers: Avoid concomitant
use of KERENDIA with strong or moderate CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS:
- Lactation: Avoid breastfeeding during treatment with
KERENDIA and for 1 day after treatment.
- 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).
Please click here for full Prescribing
Information for KERENDIA.
About Heart Failure with LVEF ≥ 40%
Heart failure is a complex clinical syndrome with symptoms and
signs that result from any structural or functional impairment of
ventricular filling or ejection of blood.5 Approximately 6.7
million adults in the U.S. suffer from HF, with about 55% having an
LVEF ≥ 40%.6 Despite the high prevalence, guideline-directed
medical treatment options for patients with HF with LVEF ≥ 40% are
limited.7 This patient group is often balancing multiple
comorbidities like obesity, hypertension and chronic kidney disease
(CKD).5 Symptoms can include shortness of breath, fatigue, chest
discomfort and swelling in the lower body.10
About Bayer’s Commitment in Cardiovascular and Kidney
Diseases
A leader in the cardiovascular (CV) space, Bayer upholds a
long-standing commitment to delivering science for a better life by
advancing research and treatment options. Bayer’s cardiorenal
franchise, which began with the discovery and development of a
number of vital therapies, now includes several products and
compounds in various stages of preclinical and clinical development
with the potential to impact the way that CV and kidney diseases
are treated.
Bayer is investigating potential treatment approaches for areas
of high unmet medical need. Currently, Bayer is investigating nine
CVR-related projects in different stages of development, including
heart failure (HF) and non-diabetic chronic kidney disease
(CKD).11
Bayer is actively identifying resources and programs aimed at
better understanding the real-world management of CKD, expanding
screening and early care management for CKD, aligning with and
supporting groups and institutions that share the common goals of
improving health outcomes, promoting health literacy and education,
and promoting research and initiatives that represent the diversity
required to address the needs of all patients.
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 2023, the Group employed approximately 100,000
people and had sales of 47.6 billion euros. R&D expenses before
special items amounted to 5.8 billion euros. For more information,
go to www.bayer.com.
Find more information at https://pharma.bayer.com/ Follow us on
Facebook: http://www.facebook.com/bayer Follow us on X:
@BayerPharma
Forward-Looking Statements
This release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer management. Various
known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results,
financial situation, development or performance of the company and
the estimates given here. These factors include those discussed in
Bayer’s public reports, which are available on the Bayer website at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
___________________________________ 1 Data on File. 2 Study to
Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone
on Morbidity (Events Indicating Disease Worsening) & Mortality
(Death Rate) in Participants With Heart Failure and Left
Ventricular Ejection Fraction (Proportion of Blood Expelled Per
Heart Stroke) Greater or Equal to 40% (FINEARTS-HF). Clinical trial
registration No. NCT04435626.
clinicaltrials.gov/study/NCT04435626?cond=NCT04435626&rank=1#study-plan.
3 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert].
U.S. Food and Drug Administration. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf.
July 2024. 4 Kosaraju A, et al. Left Ventricular Ejection Fraction.
StatPearls. April 2023.
https://www.ncbi.nlm.nih.gov/books/NBK459131/ 5 Heidenreich P, et
al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart
Failure: A Report of the American College of Cardiology/American
Heart Association Joint Committee on Clinical Practice Guidelines J
Am Coll Cardiol. 2023. https://pubmed.ncbi.nlm.nih.gov/35379503/. 6
Bozkurt A, et al. Heart Failure Epidemiology and Outcomes
Statistics: A Report of the Heart Failure Society of America. J
Card Fail. 2023 Oct;29(10):1412-1451. doi:
10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. PMID: 37797885;
PMCID: PMC10864030. 7 Desai N, et al. Heart failure with mildly
reduced and preserved ejection fraction: A review of disease burden
and remaining unmet medical needs within a new treatment landscape.
Heart Fail Rev. 2024; 29(3): 631–662.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11035416/. 8 American
Diabetes Association (Section 10: Cardiovascular disease and risk
management: standards of care in diabetes—2024.) Diabetes Care.
2024;47(Suppl. 1):S179–S218. doi:10.2337/dc24-S010. 9 Marx N, et
al. ESC Guidelines for the management of cardiovascular disease in
patients with diabetes. Eur Heart J. 2023;44(39):4043-4140.
doi:10.1093/eurheartj/ehad192 10 American Heart Association. What
is Heart Failure. Available at:
https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure.
July 2024. 11 Bayer Pharmaceuticals. Development Pipeline. U.S.
Available at:
https://www.bayer.com/en/pharma/development-pipeline.
COR-KER-US-0081-1 8/24
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Media: Elaine Colón Bayer
Media Relations Elaine.colon@bayer.com +1-732-236-1587