Kerendia™ (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study
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U.S. Food and Drug Administration (FDA) granted label update for Kerendia™ (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) / FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD associated with T2D / With early to late-stage CKD associated with T2D, FIGARO-DKD included patients across a broad range of disease severity, including stages 1-4 CKD with albuminuria
Berlin, September 2, 2022 – Bayer announced today that it received approval from the U.S. Food and Drug Administration (FDA) for a label update for Kerendia™ (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The positive data from the pivotal Phase III FIGARO-DKD study demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. Results from the trial were presented at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine.
Patients living with chronic kidney disease associated with type 2 diabetes are three times more likely to die from a cardiovascular event than those with type 2 diabetes alone. FIGARO-DKD is the first contemporary Phase III CV outcomes trial to show CV benefit in a patient population where the majority of patients was in earlier CKD stages (stages 1-2 CKD, defined as estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73m2) with albuminuria. With the addition of these study findings, the U.S. label now includes clinical trial data from more than 13,000 patients with CKD associated with T2D based on FIDELIO-DKD and FIGARO-DKD.
“Patients need to be screened regularly and treated early to prevent them from progressing to more advanced stages of chronic kidney disease, as this may lead to better outcomes for these patients, potentially preventing cardiovascular complications and death,” said Dr. Michael Devoy, Chief Medical Officer of Bayer AG's Pharmaceutical Division. “At Bayer, we are committed to providing treatment options that offer clinically meaningful benefits for patients. Reflecting the positive data from the pivotal Phase III FIGARO-DKD study on the reduction of the risk of cardiovascular events, the U.S.-label update announced today reaffirms Kerendia as a fundamental pillar in the treatment algorithm to improve outcomes in patients with chronic kidney disease associated with type 2 diabetes.”
Kerendia offers an alternative pathway to treating chronic kidney disease associated with type 2 diabetes by blocking mineralocorticoid receptor (MR) overactivation, which contributes to CKD progression and cardiovascular damage. Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia™ was granted marketing authorization by the U.S. FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal myocardial infarction (MI), and hospitalization for heart failure in adult patients with CKD associated with T2D.
Kerendia was approved by the European Commission in February 2022, and the Chinese National Medical Products Administration (NMPA) in June 2022; both approvals were based on the results of the FIDELIO-DKD study. In March 2022, Bayer submitted a Type II Variation application based on the data from FIGARO-DKD to the European Medicines Agency (EMA) to seek an extension of the finerenone marketing authorization to include early stages of CKD associated with T2D. Based on the positive results of both pivotal Phase III studies, FIDELIO-DKD and FIGARO-DKD, Kerendia™ was approved in March 2022 by the Japanese Ministry of Health, Labour, and Welfare (MHLW). Further regulatory approvals by other health authorities in multiple other countries have been granted or are currently pending following submissions for marketing authorization.
About Kerendia™ (finerenone)
Kerendia is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
The Phase III study programme with finerenone, FINEOVATE, currently comprises five Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, and FIONA, as well as the Phase II study CONFIDENCE.
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 completed and published 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.
FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program in >13,000 patients with CKD and T2D. The prespecified FIDELITY pooled analysis investigated the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D in reducing the risk of chronic kidney disease progression as well as fatal and nonfatal CV events and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes risk categories) and the effects of finerenone on composite cardiovascular and kidney-specific endpoints.
In November 2021, Bayer announced the initiation of FIONA, a multicenter, randomized, double-blind, placebo-controlled Phase III study, to investigate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of finerenone, in addition to standard of care, in approximately 200 pediatric patients with chronic kidney disease (CKD) and severely increased proteinuria.
In September 2021, Bayer announced the initiation of the Phase III study FIND-CKD, a multicenter, randomized, double-blind, placebo-controlled Phase III study to 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).
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 approximately 6000 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 February 2022, Bayer announced the initiation of the CONFIDENCE study, a Phase II, three-arm study that will investigate simultaneous initial combination therapy with finerenone and the SGLT2 inhibitor empagliflozin, compared with finerenone alone and empagliflozin alone respectively in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). The primary objective of the study is to demonstrate that the simultaneous initiation and combined use of finerenone and empagliflozin is superior to either empagliflozin alone, or finerenone alone, in reducing urine albumin-to-creatinine ratio (UACR).
About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 160 million people with T2D worldwide. Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. Patients with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.
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 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.
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Dr. Daniela Esser
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