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Berlin, November 5, 2021 – At the American Heart Association (AHA) Scientific Sessions 2021, 13-15 November, Bayer will present new data on its non-steroidal, selective mineralocorticoid receptor (MR) antagonist finerenone, the soluble guanylate cyclase (sGC) stimulator Verquvo (vericiguat), and the Factor Xa inhibitor Xarelto (rivaroxaban). The abstracts presented across Bayer’s cardiovascular (CV) portfolio highlight its ongoing commitment to improving the lives of patients with kidney and CV diseases.
Finerenone secondary analysis of FIGARO-DKD Heart Failure data:
The results of the Phase III study FIGARO-DKD, which evaluated finerenone in addition to standard of care (SoC) in a broad patient population with chronic kidney disease (CKD) and type 2 diabetes (T2D) for CV outcomes, were presented at ESC Congress in August 2021 and simultaneously published in the New England Journal of Medicine. The FIGARO-DKD study met its primary endpoint, showing that finerenone significantly reduced the composite risk of time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure. At the upcoming AHA Scientific Sessions, Bayer will present a secondary analysis from FIGARO-DKD, examining the impact of finerenone on new onset of heart failure (HF) and outcomes in patients with a history of HF at baseline.
• Finerenone in Patients With Stage 1-4 Chronic Kidney Disease and Type 2 Diabetes: A Secondary Analysis of Heart Failure From the FIGARO-DKD Trial
o November 15, 2021, 9:30-9:37 AM (EST) / 3:30-3:37 PM (CET)
o Session: FS.07 - From Failure to Success: Advances in Heart Failure
Finerenone subgroup analysis of FIDELITY:
At the upcoming AHA Scientific Sessions, Bayer will present new findings from FIDELITY, the prespecified pooled analysis of both FIDELIO-DKD and FIGARO-DKD. The aim of FIDELITY was to evaluate the efficacy and safety of finerenone in more than 13,000 patients with CKD and T2D across the spectrum in terms of disease severity. This new analysis investigated the effects of finerenone on heart failure outcomes in pre-specified subgroups of estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR).
• Finerenone in Mild to Severe Chronic Kidney Disease and Type 2 Diabetes: A FIDELITY Subgroup Analysis in Patients With Heart Failure
o November 13, 2021, 11:20-11:28 AM (EST) / 5:20-5:28 PM (CET)
o SESSION: FS.01 - Rapid Fire Secondary Trial Analyses in Heart Failure
Xarelto VOYAGER PAD study data:
New VOYAGER PAD study data will analyze the use of rivaroxaban plus aspirin in patients with chronic peripheral artery disease (PAD) and claudication following lower extremity revascularization (LER), compared to using aspirin alone:
• Risk Profile and Efficacy and Safety of Rivaroxaban in Patients Undergoing Revascularization For Claudication: Insights From VOYAGER PAD
o November 15, 2021, 8:16-8:24 AM (EST) / 2:16-2:24 PM (CET)
o Session: FS.06 - Improving Interventions for Vascular Disease
Verquvo VICTORIA study data:
A health economic analysis of the Phase III VICTORIA trial will provide new insights into the potential cost-effectiveness of vericiguat (Verquvo™) in patients with heart failure with reduced ejection fraction:
• Cost Effectiveness of Vericiguat in Patients with Heart Failure with Reduced Ejection Fraction: Results from the VICTORIA Trial
o November 15, 2021, 9:57-10:04 AM (EST) / 3:57-4:04 PM (CET)
o Session: FS.07 - From Failure to Success: Advances in Heart Failure
Verquvo is being jointly developed with MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA).
Finerenone (BAY 94-8862) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation. In T2D, MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. The Phase III study program with finerenone, FINEOVATE, currently comprises four Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF and FIND-CKD.
Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D.
In June 2020, Bayer 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 (New York Heart Association class II-IV) with preserved ejection fraction, i.e. 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 (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits).
In September 2021, Bayer announced the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone in patients with non-diabetic chronic kidney disease. FIND-CKD will investigate the efficacy and safety of finerenone in addition to guideline-directed therapy on the progression of chronic kidney disease (CKD) in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys). The primary outcome measure is the mean rate of change in kidney function over time (estimated glomerular filtration rate, eGFR slope) from baseline to month 32.
About Rivaroxaban (XareltoTM)
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto. Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions than any other NOAC:
• The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors
• The treatment of pulmonary embolism (PE) in adults
• The treatment of deep vein thrombosis (DVT) in adults
• The prevention of recurrent PE and/or DVT in adults
• The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
• The prevention of VTE in adult patients undergoing elective knee replacement surgery
• The prevention of atherothrombotic events after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
• The prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events when co-administered with acetylsalicylic acid (ASA)
• Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment
Xarelto is approved in more than 130 countries, although the approved labelling, including the number of indications, may differ from country to country. Since launch in 2008, more than 91 million patients have been treated.
Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).
Anticoagulant medicines are therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating treatment with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.
To learn more about thrombosis, please visit www.thrombosisadviser.com and www.vascularadviser.com
To learn more about Xarelto, please visit www.xarelto.com
About Vericiguat (VerquvoTM)
Verquvo 2.5 mg, 5 mg, and 10 mg is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.
About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate 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 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.
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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.
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