Not intended for U.S. and UK Media
Berlin, May 17, 2023 – Bayer announced today that the Chinese National Medical Products Administration (NMPA) granted marketing authorization for a label extension for Kerendia™ (finerenone) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is now indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adult patients with CKD associated with T2D (with albuminuria).
Results from the pivotal Phase III FIGARO-DKD study were presented at the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in the New England Journal of Medicine. 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 and T2D. The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D versus placebo.
“Early intervention in chronic kidney disease is essential to delay disease progression,” said Professor Zhu Dalong, Department of Endocrinology, Nanjing Drum Tower Hospital, Nanjing Medical School, China. “Chronic Kidney Disease is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. People with type 2 diabetes should have their urine tested regularly for albumin by a doctor and once diagnosed should be treated comprehensively to reduce the risk of cardiovascular complications and death. The Phase III FIGARO-DKD study included patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D. The label extension for Kerendia provides clinicians and patients with an effective option for early treatment.”
“China has a considerable burden of diabetes. In 2021, 141 million adults in China were living with diabetes, being at risk of serious complications like CKD. Up to 40% of all patients with type 2 diabetes develop CKD, so they should be regularly monitored by their doctor for the earliest signs of kidney disease,” said Dr. Michael Devoy, Chief Medical Officer of Bayer’s Pharmaceuticals Division. “The Chinese label update announced today endorses Kerendia as a cornerstone treatment offering physicians a distinct path to protect patients with chronic kidney disease associated with type 2 diabetes from further kidney damage and cardiovascular events.”
Mineralocorticoid receptor (MR) overactivation contributes to CKD progression and CV damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Addressing an alternative pathway, Kerendia offers protection as it selectively binds to the MR receptor, blocking harmful effects of MR overactivation.
Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted initial marketing authorization by the Chinese National Medical Products Administration (NMPA) in June 2022 for the treatment of CKD (eGFR of ≥ 25 to 75 mL/min/1.73 m2 with albuminuria) associated with type 2 diabetes in adults, to reduce the risk of sustained eGFR decline and end-stage kidney disease. The label extension for Kerendia to include earlier stages of chronic kidney disease associated with type 2 diabetes and reduce patient’s risk of cardiovascular outcomes now reflects data from more than 13,000 patients with CKD and T2D, based on both the Phase III FIDELIO-DKD and FIGARO-DKD studies.
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.
Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia™ was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in July 2021, the European Commission in February 2022, and the Chinese National Medical Products Administration (NMPA) in June 2022. In September 2022, Bayer announced that it received approval from the U.S. FDA for a label update for Kerendia™ to include findings from the Phase III FIGARO-DKD CV outcomes study. In February 2023, based on the Phase III FIGARO-DKD findings, Kerendia™ received approval from the European Commission for a label extension, 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 and label updates.
The Phase III study program 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, FIDELIO-DKD and FIGARO-DKD, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.
The prespecified FIDELITY pooled analysis, including the FIDELIO-DKD and FIGARO-DKD studies, 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 – KDIGO – risk categories) and the effects of finerenone on composite kidney and CV-specific endpoints.
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 190 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.
About Bayer
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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.
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