Bayer : Finerenone slowed kidney function decline and reduced kidney-cardiovascular risk versus placebo in patients with hypertensive nephropathy

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Continue DocCheck-EN SPECIALIZED PRESS Export-LatestNews Export-PH Research & Innovation Pharmaceuticals Cardiovascular Diseases Bayer August 30 , 2026 | 13:44 PM Europe/Amsterdam Not intended for U.S. and UK Media - Late breaking data presented at ESC Congress 2026: Finerenone slowed kidney function decline and reduced kidney-cardiovascular risk versus placebo in patients with hypertensive nephropathy Summary A pre-specified subgroup analysis of the Phase III FIND-CKD study found that finerenone slowed kidney function decline compared with placebo in addition to standard of care in patients with hypertensive nephropathy, a population for whom there are only few guideline-directed treatment options / Finerenone also reduced the risk of the key secondary endpoint, a composite of kidney-cardiovascular outcomes, versus placebo in addition standard of care in this subgroup / Hypertension is a common c ause of chronic kidney disease (CKD), and overactivation of the mineralocorticoid receptor is a key contributor to the underlying pathophysiology of both hypertension and CKD / The new data were presented within a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany Berlin, August 30, 2026 - Positive results from a pre-specified subgroup analysis of the Phase III FIND-CKD trial were presented today during a Late-Breaking Clinical Science session at ESC Congress 2026 in Munich, Germany. The analysis showed that finerenone (Kerendia™/Firialta™) slowed kidney function decline and reduced kidney-cardiovascular risk compared with placebo, in addition to standard of care, in patients with hypertensive nephropathy. "Hypertension is one of the most common causes of chronic kidney disease, yet there are still very few treatments that have been shown to address the high risk of kidney function decline and cardiovascular events in adults with chronic kidney disease attributed to hypertension," said Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Co-Chair of the FIND-CKD study's Executive Committee. "For clinicians, the findings offer new insights into the benefits of finerenone in cardio-kidney health protection in patients with hypertensive nephropathy." Key findings from the pre-specified FIND-CKD subgroup analysis For the subgroup analysis, 459 patients with hypertensive nephropathy out of the 1,584 participants randomized in FIND-CKD (29.0%) were included, with 234 patients randomized to receive finerenone and 225 randomized to placebo. The primary outcome of the FIND-CKD study was estimated glomerular filtration rate (eGFR) change over time from baseline to 32 months (= total eGFR slope). The eGFR slope is a validated surrogate endpoint for clinical kidney outcomes. In the subgroup, eGFR slope decline was slower with finerenone compared to placebo (−3.17 vs. −3.82 mL/min/1.73 m² per year; a between-arm difference of 0.65 mL/min/1.73 m² per year [95% CI, 0.02-1.29; p=0.044]). Finerenone also reduced the risk of the key secondary kidney-cardiovascular endpoint, a composite of kidney failure, sustained ≥57% decline in eGFR, hospitalization for heart failure, or cardiovascular death, which occurred in 12.0% of patients receiving finerenone compared with 18.7% receiving placebo (hazard ratio [HR], 0.61; 95% CI, 0.38-0.99; p=0.045) in this subgroup. At month 6, urine albumin-to-creatinine ratio (UACR) was reduced in patients receiving finerenone by 33% (95% CI, 23-41). Finerenone reduced systolic blood pressure at month 6 compared with placebo with a between-group difference of −3.5 mmHg (95% CI: −6.0 to -1.0). Finerenone was well-tolerated in this subgroup, which is consistent with the safety profile observed in the overall FIND-CKD trial population and consistent with the well-established safety profile of finerenone. High unmet need in patients with hypertension-related CKD Worldwide, approximately 850 million people are living with CKD, with hypertension-related kidney disease being the second most common cause of kidney failure globally. Patients with advanced non-diabetic CKD across diverse etiologies face a significantly increased risk of fatal cardiovascular events, about 2.6 times higher than that of the general population without CKD, with the risk increasing further as kidney function declines. Despite current standard of care, many of these patients continue to experience disease progression, highlighting the need for new treatment approaches. Overactivation of the mineralocorticoid receptor (MR) is a key contributor to the underlying pathophysiology of both hypertension and CKD. "This prespecified subgroup analysis adds to the breadth and depth of the robust evidence supporting the clinical utility of finerenone seen so far across its clinical development program in heart failure and chronic kidney disease, while deepening our understanding of its potential benefits in patients with diverse causes of chronic kidney disease," said Dr. Christian Rommel, Global Head of Research and Development at Bayer's Pharmaceuticals Division. "The consistency of the data generated to date reinforces our confidence in finerenone and our commitment to advancing research that may help improve outcomes for patients living with cardio-kidney conditions." Finerenone is marketed as Kerendia™ or, in some countries as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 100 countries worldwide, including in China, Europe, Japan and the U.S. Finerenone is also approved for the treatment of heart failure with LVEF ≥40% in the U.S., Europe, Japan, China, and several other markets. Finerenone is currently not approved for the treatment of non-diabetic CKD. About Kerendia ™ / Firialta ™ (finerenone) Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. About FIND-CKD FIND-CKD ( FI nerenone, in addition to standard of care, on the progression of kidney disease in patients with N on- D iabetic C hronic K idney D isease; NCT05047263) is the largest Phase III study to date focused on diverse etiologies of non-diabetic CKD, and the fifth completed Phase III study to report positive results with finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), which so far was studied in more than 20,000 patients across multiple patient populations with chronic kidney disease and/or heart failure. FIND-CKD was a multicenter, randomized, double-blind, Phase III, placebo-controlled trial that enrolled 1,584 participants with CKD without diabetes across 283 sites, including kidney disease linked to hypertension and glomerular diseases. Participants had an eGFR of 25 to <90 mL/min/1.73 m² and albuminuria (UACR 200 to ≤3500 mg/g) and were on the maximum tolerated dose of a renin-angiotensin system (RAS) inhibitor. Participants were randomized 1:1 to receive finerenone (10 or 20 mg once daily) or matching placebo on top of maximum tolerated labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). The primary endpoint of FIND-CKD was the mean annual rate of change in eGFR (total eGFR slope) from baseline to Month 32. Secondary endpoints included a composite of kidney failure, sustained ≥57% eGFR decline, hospitalization for heart failure, or cardiovascular death; a kidney-specific composite of kidney failure or sustained ≥57% eGFR decline; and a cardiovascular-specific composite of hospitalization for heart failure or cardiovascular death. 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com . Contact for media inquiries: Dr. Daniela Esser, phone +49 30 2215-41588 Email: [email protected] Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer de (2026-0138e) 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. Bayer AG is a holding company with operating subsidiaries worldwide. References to "Bayer" or "the company" herein may refer to one or more subsidiaries as context requires. Contact Dr. Daniela Esser Cardiology [email protected] +49 30 2215-41588 Downloads 2026-0138e.pdf 2026-0138e.rtf Sign up for our Newsletter We will keep you informed about the latest news. Sign up Newsroom

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