Health Canada approves KERENDIA® (finerenone) as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D)

• Finerenone is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes¹
• The approval is based on the results of the Phase III FIDELIO-DKD and FIGARO-DKD studies investigating the efficacy and safety of finerenone on kidney and cardiovascular (CV) outcomes in patients with CKD associated with T2D
• Despite guideline-directed therapies, many patients with chronic kidney disease associated with type 2 diabetes still progress to loss of kidney function and are at high risk for cardiovascular events^2,3,4

MISSISSAUGA, ON, Oct. 26, 2022 /CNW/ - Bayer Inc. announced today that Health Canada approved finerenone, under the brand name KERENDIA^®, as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease and a sustained decrease in estimated glomerular filtration rate, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure⁵. Finerenone is available in two tablet strengths – 10 mg and 20 mg.

The approval of finerenone by Health Canada is based on the positive results of the pivotal Phase III FIDELIO-DKD and FIGARO-DKD studies. FIDELIO-DKD was presented at the American Society of Nephrology's (ASN) Kidney Week Reimagined 2020 and simultaneously published in the New England Journal of Medicine in October 20201. FIGARO-DKD was presented at the European Society of Cardiology (ESC) Congress on August 28, 2021 and published in the New England Journal of Medicine in December 2021⁶.

"There is an unmet need for patients with kidney disease from diabetes, it remains the number one cause of end stage kidney disease requiring dialysis in Canada and triples the risk of dying from cardiovascular disease over type 2 diabetes alone," said Dr. Sheldon Tobe, University of Toronto Postgraduate Fellowship Director – Nephrology and Professor of Medicine, University of Toronto and Northern Ontario School of Medicine. "For patients with diabetic kidney disease across a wide range of severity, the addition of finerenone to standard of care produced a dramatic improvement in the risk of heart disease and the risk of loss of kidney function and the need for dialysis. For patients who develop diabetes today, I believe that finerenone together with our best therapies, has the potential to improve cardiovascular outcomes and prevent the need for dialysis over their lifetime."

Chronic kidney disease is a common and potentially deadly condition that is generally underrecognized. CKD can shorten life expectancy of patients with type 2 diabetes by up to 16 years relative to the general population living without either disease. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. In T2D, mineralocorticoid receptor (MR) overactivation is thought to contribute to CKD progression which can be driven by metabolic, haemodynamic or inflammation and fibrosis factors^1,4,7,8,9.

"FIDELIO-DKD is the first large contemporary Phase III positive outcomes study in patients with chronic kidney disease and type 2 diabetes with a primary composite endpoint consisting exclusively of kidney-specific outcomes, while FIGARO-DKD is the first contemporary Phase III CV outcomes trial with the majority of patients with earlier stage (1-2) CKD with albuminuria to show CV benefit in patients with CKD associated with T2D. These two trials are a part of the largest global Phase III clinical trial program to date in CKD and T2D," said Dr. Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs for Bayer Canada. "With our longstanding expertise in innovative science in the cardiovascular space, today's approval of finerenone marks an important milestone in Bayer's commitment to improving the lives of patients with kidney and cardiovascular diseases."  

About Finerenone

Finerenone (BAY 94-8862) is a non-steroidal, selective antagonist of the mineralocorticoid receptor that has been shown to block harmful effects of mineralocorticoid receptor overactivation. In T2D, MR overactivation is thought to contribute to CKD progression and cardiovascular damage, which can be driven by metabolic, haemodynamic or inflammation and fibrosis factors^1,4,7,8,9. Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III programme 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 T2D5.

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 across 47 countries including sites in Europe, Japan, China and the U.S. Both FIDELIO-DKD and FIGARO-DKD studies met their primary endpoints.

Finerenone was generally well-tolerated with similar overall rates of adverse events in the finerenone and placebo arms of both clinical trials. The most common adverse reaction associated with finerenone was hyperkalemia. This was expected based on the mechanism of action. Hyperkalemia events were generally manageable by temporary interruption of finerenone with few permanent treatment discontinuations. There were no observed deaths due to hyperkalemia in either study^1,6.

KERENDIA^® has already been approved by a number of health authorities, including the U.S. Food and Drug Administration (FDA) in July 2021 and by the European Commission for marketing authorization in the European Union (EU) in February 2022.

About Chronic Kidney Disease in Type 2 Diabetes

Chronic kidney disease (CKD) is a potentially deadly condition that is generally underrecognized – one in 10 Canadians has kidney disease¹⁰. 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 CKD. 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. CKD in T2D is the main cause of end stage kidney disease¹¹, which requires dialysis or a kidney transplant to stay alive¹².

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 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 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.ca. 

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.

Reference

____________________________________

¹ Bakris G et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. New England Journal of Medicine. 2020. 383, 2219-2229.

² Anders H J et al. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nature Reviews Nephrology. 2018. 14, 361–377.

³ Thomas M C, et al. Diabetic kidney disease. Nature Reviews Disease Primers. 2015. 1, 1-20.

⁴ Alicic R Z et al. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clinical Journal of the American Society of Nephrology. 2017. 12(12), 2032–2045.

⁵ KERENDIA^® Product Monograph, Bayer Inc., https://www.bayer.com/sites/default/files/kerendia-pm-en.pdf, October 14, 2022.

⁶ Pitt B et al. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. New England Journal of Medicine. 2021. 385, 2252-2263

⁷ Bauersachs J, et al. Mineralocorticoid receptor activation and mineralocorticoid receptor antagonist treatment in cardiac and renal diseases. Journal of Hypertension. 2015. 65, 257-263.

⁸ Black L M, et al. Renal Inflammation and Fibrosis: A Double-edged Sword. Journal of Histochemistry and Cytochemistry. 2019. 67(9), 663-681.

⁹ Kolkhof P et al. Steroidal and Novel Non-steroidal Mineralocorticoid Receptor Antagonists in Heart Failure and Cardiorenal Diseases: Comparison at Bench and Bedside. Heart Failure. Handbook of Experimental Pharmacology. 2017. 243, 271-305.

¹⁰ Kidney Foundation. Available at: https://kidney.ca/KFOC/media/images/PDFs/Facing-the-Facts-2020.pdf. [Last accessed: October 2022].

¹¹ Doshi S M, et al. Diagnosis and Management of Type 2 Diabetic Kidney Disease. Clinical Journal of the American Society of Nephrology. 2017. 12(8), 1366-1373.

¹² KidneyFund.org. Kidney Failure. Available at: https://www.kidneyfund.org/kidney-disease/kidney-failure/. [Last accessed: January 2022].

SOURCE Bayer Inc.

Bayer Inc., Communications Department, [email protected]