New CKD drug Kerendia lands in general hospitals in KOR

chronic kidney disease treatment

Passes Drug Committee review at Sinchon Severance Hospital…starts landing procedures at major hospitals in Korea

Signed a co-promotion agreement with Chong Kun Dang…Full-scale promotion to start in February

The landing procedure for the new chronic kidney disease drug 'Kerendia' is in full swing in general hospitals in Korea ahead of its reimbursement listing.

 

According to industry sources, Bayer Korea's Kerendia (finerenone) recently passed the drug committee (DC) review at Sinchon Severance Hospital.

 

It is also undergoing a landing process at major hospitals nationwide.

 

Kerendia, a treatment for chronic kidney disease associated with type 2 diabetes, will be listed for reimbursement next month (February).

 

With Chong Kun Dang joining as a domestic sales partner, full-scale promotional activities are expected to unfold along with the rapid landing process.

 

Kerendia was approved in Korea last year as a treatment for adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease (ESKD) and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure.

 

CKD is one of the most common complications of type 2 diabetes and an independent risk factor for cardiovascular disease.

 

Although it is a progressive disease, it is difficult to detect because there are no specific symptoms until just before end-stage renal failure.

 

In addition, when end-stage renal failure occurs, dialysis or kidney transplantation is required to maintain life, which not only imposes a significant social and economic burden but also significantly affects the patient's quality of life.

 

Therefore, patients with type 2 diabetes need to be monitored regularly for kidney damage with kidney function tests, it is important to slow the progression of kidney disease and lower the risk of cardiovascular disease through early diagnosis and appropriate treatment.

 

Three main factors are known contributors to kidney disease in type 2 diabetes: hemodynamic changes, metabolic abnormalities, and inflammation and fibrosis.

 

However, current treatments primarily target hemodynamic and metabolic factors, raising the need for new therapies that target the inflammation and fibrosis factor.

 

Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that has a novel mechanism of action that targets inflammation and fibrosis in adult chronic kidney disease with type 2 diabetes.

 

Overactivation of the mineralocorticoid receptors can cause inflammation and fibrosis, which can lead to permanent kidney damage.

 

By inhibiting the overactivation of the mineralocorticoid receptor, Kerendia reduces inflammation and fibrosis and inhibits kidney damage.

 

Bayer demonstrated Kerendia’s efficacy through the Phase III trial (FIDELIO-DKD).

 

In the study, which enrolled approximately 5,700 patients in 48 countries worldwide, Kerendia was found to reduce chronic kidney disease progression and reduce cardiovascular disease risk in adult patients with chronic kidney disease and type 2 diabetes.

 

Patients in the study received 10 mg or 20 mg of Kerendia or placebo in addition to standard therapy.

 

Results showed Kerendia significantly reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2 ), or renal death by 18% compared with placebo.

 

In addition, Kerendia reduced the major secondary outcome – a composite of time to first 9 occurrences of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure – by 14%.

 

The overall rate of serious adverse events or acute kidney injury-related adverse events was comparable between the two groups.

 

Meanwhile, the European Society of Cardiology (ESC) published a major revision of its 2021 guidelines for the diagnosis and treatment of acute or chronic heart failure (HF), which included Kerendia as a Class 1A recommendation in preventing hospitalization for heart failure in patients with chronic kidney disease with type 2 diabetes.

 

In addition, the ESC recommended that patients measure their glomerular filtration rate and urinary albumin levels once a year to screen for the development of chronic kidney disease in patients with diabetes.