Health Canada approves KERENDIA® (finerenone) as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2DM)

  • Finerenone is the first non-steroidal selective mineralocorticoid (MR) receptor antagonist to demonstrate positive renal and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes1

  • Approval is based on results from the Phase III FIDELIO-DKD and FIGARO-DKD studies investigating the efficacy and safety of finerenone on renal and cardiovascular (CV) outcomes in patients with CKD associated with T2DM

  • 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.two,3,4

MISSISSAUGA, IN🇧🇷 October 26, 2022 /CNW/ – Bayer Inc. today announced that Health Canada has approved finerenone under the brand name KERENDIA🇧🇷as an adjunct to standard therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2DM) to reduce the risk of end-stage renal disease and a sustained decrease in estimated glomerular filtration rate, cardiovascular death, fatal myocardial infarction, and hospitalization for heart failure5🇧🇷 Finerenone is available in two tablet strengths – 10 mg and 20 mg.

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

“There is an unmet need for patients with kidney disease from diabetes, which remains the number one cause of end-stage kidney disease requiring dialysis in Canada and triples the risk of dying from cardiovascular disease with type 2 diabetes alone,” said Dr. Sheldon Tobe🇧🇷 university of toronto Director of the Graduate Scholarship – Nephrology and Professor of Medicine, university of toronto and Northern Ontario School of Medicine. “For patients with diabetic kidney disease over a wide range of severity, adding finerenone to standard care has produced a dramatic improvement in the risk of heart disease and the risk of loss of kidney function and need for dialysis. For patients who develop diabetes today, I believe finerenone, along with our best therapies, has the potential to improve cardiovascular outcomes and prevent the need for lifelong dialysis.”

Chronic kidney disease is a common and potentially deadly condition that is often underestimated. CKD can shorten the 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 DM2, overactivation of the mineralocorticoid receptor (MR) is believed to contribute to the progression of CKD, which may be driven by metabolic, hemodynamic, or inflammation and fibrosis factors1,4,7,8,9🇧🇷

“FIDELIO-DKD is the first large contemporary study of positive Phase III outcomes 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 of Phase III CV results with most early-stage (1-2) CKD patients with albuminuria to show CV benefit in patients with CKD associated with T2DM. These two trials form part of the largest global Phase III clinical trial program III to date in CKD and DM2,” said Dr. Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs, Bayer Canada. “With our long-standing experience in groundbreaking 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 disease.”

About Finerenone

Finerenone (BAY 94-8862) is a selective nonsteroidal mineralocorticoid receptor antagonist that has been shown to block the deleterious effects of mineralocorticoid receptor overactivation. In T2DM, MR overactivation is thought to contribute to CKD progression and cardiovascular damage, which may be caused by metabolic, hemodynamic, or inflammation and fibrosis factors.1,4,7,8,9🇧🇷 Having randomized over 13,000 patients with CKD and T2DM worldwide, the Phase III program with finerenone in CKD and T2DM comprises two studies, evaluating the effect of finerenone versus placebo on top of standard care on renal and cardiovascular outcomes. FIDELIO-DKD (FInerone in ki reductionDnANDI doIure edIsese prOaggression in Ddiabetic kidney Disease) investigated the efficacy and safety of finerenone compared to placebo in addition to standard care in reducing renal failure and renal disease progression in approximately 5700 patients with CKD and T2DM5.

FIGARO-DKD (FINerona in reduceG çONEcardiovascular diseaseRsuchness inOrbity in Ddiabetic kidney Disease) investigated the efficacy and safety of finerenone versus placebo and standard of care in reducing cardiovascular morbidity and mortality in approximately 7400 patients with CKD and T2DM in 47 countries, including sites in Europe🇧🇷 Japan🇧🇷 China and the FIDELIO-DKD and FIGARO-DKD studies in the US met their primary endpoints.

Finerenone was generally well tolerated with similar overall rates of adverse events in the finerenone and placebo arms of both trials. The most common adverse reaction associated with finerenone was hyperkalemia. This was expected based on the mechanism of action. Hyperkalemia events were generally controlled by temporarily stopping finerenone with few permanent discontinuations of treatment. There were no observed deaths due to hyperkalemia in any of the studies.1.6🇧🇷

KERENDIA🇧🇷 has already been approved by several health authorities, including the US 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 often goes unrecognized – one in 10 Canadians has kidney disease10🇧🇷 CKD is one of the most frequent complications of diabetes and is also an independent risk factor for cardiovascular disease. Up to 40% of all patients with type 2 diabetes develop CKD. Despite guideline-directed therapies, patients with CKD and T2DM remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 160 million people with DM2 worldwide. CKD in DM2 is the main cause of end-stage renal disease11that requires dialysis or a kidney transplant to stay alive12🇧🇷

About Bayer’s commitment to cardiovascular and kidney disease

Bayer is an innovation leader in the field of cardiovascular disease, with a long-standing commitment to delivering science for a better life by developing a portfolio of innovative treatments. The heart and kidneys are closely linked in health and disease, and Bayer is working across a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. Bayer’s cardiology franchise 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 research approach, which prioritizes goals and pathways with the potential to impact the way cardiovascular disease is treated.

About Bayer

Bayer is a global company with core competencies in the life sciences of healthcare and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to overcome key challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact on its businesses. At the same time, the Group aims to increase its purchasing power and create value through innovation and growth. The Bayer brand represents trust, reliability and quality around the world. In fiscal 2021, the Group employed around 100,000 people and had sales of €44.1 billion. R&D spending before special items totaled €5.3 billion. For more information, visit www.bayer.ca.

Forecast 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 condition, 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 Bayer’s website at www.bayer.com. The company assumes no responsibility 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.

two Anders HJ et al. CKD in diabetes: diabetic kidney disease versus non-diabetic kidney disease. Nature Reviews Nephrology🇧🇷 2018. 14, 361–377.

3 Thomas MC, and others. Diabetic kidney disease. Nature Reviews disease primers🇧🇷 2015. 1, 1-20.

4 Alicic RZ 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. Hypertension Magazine. 2015. 65, 257-263.

8 Black LM, and others. Renal inflammation and fibrosis: a double-edged sword. Journal of Histochemistry and Cytochemistry. 2019. 67(9), 663-681.

9 Kolkhof P et al. Steroid and novel non-steroidal mineralocorticoid receptor antagonists in heart failure and cardiovascular disease: benchtop and bedside comparison. Cardiac insufficiency. 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 SM, and others. 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.

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Health Canada approves KERENDIA® (finerenone) as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2DM)

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