Bayer receives approval in Japan for Kerendia™ (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes

Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure or premature death / Kerendia™ (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD and T2D / The approval is based on the results of the Phase III studies FIDELIO-DKD and FIGARO-DKD, investigating the efficacy and safety of finerenone on both kidney and cardiovascular outcomes in patients with CKD and T2D

Bayer announced today that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has granted marketing authorization for finerenone under the brand name Kerendia. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is approved for the treatment of chronic kidney disease and type 2 diabetes, excluding patients with end-stage renal disease or on dialysis. The approval is based on the results of the pivotal Phase III studies, FIDELIO-DKD and FIGARO-DKD. The FIDELIO-DKD study was presented at the American Society of Nephrology’s (ASN) Kidney Week 2020; the FIGARO-DKD study was presented at ESC Congress 2021. Both studies were published in the New England Journal of Medicine simultaneously with the congress presentations in October 2020 and August 2021, respectively.

In Japan, an estimated 13.3 million people have chronic kidney disease (CKD), a common and potentially deadly condition that is widely underrecognized. Type 2 diabetes and high blood pressure are the most common causes of CKD. Up to 40% of people with T2D will develop CKD. Finerenone is different to existing CKD in T2D treatments. It acts by blocking mineralocorticoid receptor (MR) overactivation, which contributes to CKD progression and cardiovascular damage.

“There is a high burden of type 2 diabetes in Japan, and a large proportion of people with type 2 diabetes develop chronic kidney disease. Despite well-controlled blood glucose levels and blood pressure, patients with chronic kidney disease and type 2 diabetes remain at risk of chronic kidney disease progression and cardiovascular death,” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division. “We look forward to providing patients and physicians in Japan with a new treatment option to delay kidney disease progression and reduce the risk of cardiovascular events. The approval of finerenone offers a new path to protect patients from further kidney and cardiovascular damage through addressing MR overactivation, a key driver of CKD progression, which is unaddressed by currently available therapies.”

Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization in the European Union in February 2022 and was approved by the U.S. Food and Drug Administration (FDA) in July 2021. Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these applications are currently under review.

About Kerendia ® (finerenone)
Kerendia is anon-steroidal, picky mineralocorticoid receptor (MR) antagonist that has been shown to block dangerous goods of MR overactivation. In T2D, MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or seditious and fibrotic factors.

The Phase III study programme with finerenone, FINEOVATE, presently 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 further than cases with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, assessing the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular issues. FIDELIO-DKD (FInerenone in reducing order faiLure and complaint prOgression in Diabetic Order Complaint) delved the efficacity and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of order failure and order complaint progression in roughly cases with CKD and T2D. FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Order Complaint) delved the efficacity and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in roughly cases with CKD and T2D.

Dedication (FInerenone in habitual order complaint 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 issues clinical trial program in> cases with CKD and T2D. The prespecified Dedication pooled analysis delved the efficacity and safety of finerenone across the diapason of cases with CKD in T2D in reducing the threat of habitual order complaint progression as well as fatal and nonfatal CV events, and handed perceptivity into the relationship between CKD stage ( grounded on birth Order Complaint Perfecting Global Issues threat orders) and the goods of finerenone on compound cardiovascular and order-specific endpoints.

About Habitual Order Complaint in Type 2 Diabetes
Habitual order complaint( CKD) is a common and potentially deadly condition that’s extensively underrecognized. CKD progresses quietly and unpredictably, with numerous symptoms not appearing until the complaint is well- advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent threat factor of cardiovascular complaint. Up to 40 of all cases with type 2 diabetes develop habitual order complaint. Despite guideline- directed curatives, cases with CKD and T2D remain at high threat of CKD progression and cardiovascular events. It’s estimated that CKD affects further than 160 million people with T2D worldwide. Habitual order complaint in type 2 diabetes is the main cause of end stage order complaint, which requires dialysis or a order transplant to stay alive. Cases with habitual order complaint and type 2 diabetes are three times more likely to die from a cardiovascular-affiliated cause than those with type 2 diabetes alone.

About Bayer
Bayer is a global enterprise with core capabilities in the life wisdom fields of health care and nutrition. Its products and services are designed to help people and earth thrive by supporting sweats to master the major challenges presented by a growing and growing global population. Bayer is committed to drive sustainable development and induce a positive impact with its businesses. At the same time, the Group aims to increase its earning power and produce value through invention and growth. The Bayer brand stands for trust, trustability and quality throughout the world. In financial 2021, the Group employed around people and had deals of44.1 billion euros. R&D charges before special particulars amounted to5.3 billion euros.

Source link:https://media.bayer.com/