Bayer Submits Application to EMA for Kerendia (finerenone) Label Expansion to Include Early-Stage CKD in Type 2 Diabetes Patients

News on March 24, 2022 /BioValleyBIOON/ --BayerBayer recently announced that it has submitted a Type II variation application to the European Medicines Agency (EMA) to expand the marketing authorization of Kerendia (finerenone, 10mg or 20mg) to include:Compared with Type 2Diabetes(T2D)-related early-stage chronic kidney disease (CKD).

Kerendia is the first non-steroidal, selective MRA to demonstrate positive renal and cardiovascular outcomes in CKD patients with T2D. Despite guideline-directed therapies, many CKD patients with T2D still progress to kidney failure and remain at high risk for cardiovascular events. Kerendia's mechanism of action differs from existing treatments; by blocking excessive MR activation, the drug directly targets inflammation and fibrosis to slow disease progression.

It is estimated that CKD affects more than 160 million people with T2D worldwide. Despite the availability of current treatment options, many patients with T2D-related CKD progress to kidney failure or premature death. These patients urgently need therapies that can slow kidney disease progression and reduce the risk of cardiovascular events. As the first non-steroidal MR antagonist, Kerendia will offer a new treatment option for adult patients with T2D-related CKD, helping to improve renal outcomes.

Finerenone Chemical Structure (Image Source: newdrug)approvals.org）

This application is based on the positive results of the pivotal Phase 3 FIGARO-DKD study. The FIGARO-DKD study included patients with various levels of disease severity, including CKD stages 1-4 associated with T2D. The relevant results were announced at the 2021 European Society of Cardiology (ESC) Congress and simultaneously published in the international medical journal *The New England Journal of Medicine* (NEJM). For details, see:Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes。

Data show:In a broad patient population with CKD stages 1-4 and T2D, when combined with standard care, Kerendia reduced the risk of cardiovascular (CV) events compared to placebo.In the study, both groups of patients received standard care, including hypoglycemic treatment and maximum tolerated doses of renin-angiotensin system (RAS) blockade therapy, such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).

Specifically: When combined with the maximum tolerated dose of guideline-directed therapy,During a median follow-up of 3.4 years, compared with placebo, Kerendia significantly reduced the risk of the composite primary endpoint (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure) by 13% (relative risk reduction, HR=0.87 [95% CI: 0.76-0.98]; p=0.0264).Moreover, the effect of finerenone on the primary outcome was generally consistent across pre-specified subgroups, including baseline estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) categories. In this study, finerenone was well-tolerated, with a safety profile consistent with previous studies.

Building on the pivotal Phase 3 FIDELIO-DKD study, the FIGARO-DKD study adds important evidence of finerenone's CV benefits in a broader patient population. The FIDELIO-DKD study demonstrated that finerenone improved the primary composite renal endpoint and the key secondary composite CV endpoint in patients with stage 3-4 CKD and severely elevated proteinuria.

According to the results of the FIDELIO-DKD study, in February 2022,EU Approves Kerendia (10mg or 20mg): For Adult Patients, Treatment of Type 2Diabetes(Chronic Kidney Disease (CKD, Stage 3 and 4 with Proteinuria) Associated with Type 2 Diabetes (T2D)). July 2021,United StatesFDAApproval of Kerendia for the treatment of adult patients with CKD and T2D, to reduce the risks of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease (ESKD), cardiovascular death, non-fatal myocardial infarction, and heart failure hospitalization.Currently, the drug is also undergoing regulatory review in China and several other countries.

Chronic Kidney Disease (CKD) isDiabetesOne of the most common complications, and an independent risk factor for cardiovascular disease. In all type 2DiabetesAmong patients, approximately 40% will progress to CKD. CKD is the leading cause of end-stage renal disease and kidney failure. In advanced stages, patients may require dialysis or a kidney transplant to sustain life.

Over a 10-year period, patients with type 2 diabetes and CKD are three times more likely to die from cardiovascular-related diseases compared to those with type 2 diabetes alone. It is well-known that in patients with type 2 diabetes and CKD, overactivation of the mineralocorticoid receptor triggers harmful processes (e.g., inflammation and fibrosis) in the kidneys and heart. Globally, CKD in patients with type 2 diabetes is the leading cause of renal failure.

Currently, the finerenone Phase III clinical program includes five Phase III studies (FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, FIONA). In treating CKD patients with T2D, two Phase III studies (FIDELIO-DKD, FIGARO-DKD) have been completed, enrolling a total of 13,000 patients with a wide range of CKD severity levels from around the globe, including those with early kidney damage and more advanced kidney disease. These studies evaluated the impact of finerenone versus placebo, each combined with standard care, on renal and cardiovascular (CV) outcomes. (Bioon.com)

Source of Original Text:Bayer submits application in the EU for an extension of the indication of finerenone to include early stages of chronic kidney disease associated with type 2 diabetes