CKD drug Kerendia seeks indication expansion in KOR

Received approval to initiate a Phase III trial in Korea

Will conduct trial on patients with left ventricular ejection fraction 40% or higher

Bayer Korea's Kerendia (finerenone), which is used to treat adult patients with chronic kidney disease with type 2 diabetes, will enter Phase III clinical trials in Korea to expand its indication.

 

On the 20th, the Ministry of Food and Drug Safety (MFDS), approved a ‘randomized clinical trial to determine the efficacy and safety of finerenone on the morbidity and mortality of heart failure patients with left ventricular ejection fraction greater than 40% who were hospitalized for acute non-targeted heart failure episodes.’ Kerendia, which received domestic approval in May 2022, is indicated for the sustained reduction in estimated glomerular filtration rate (eGFR), progression to end-stage renal disease, and reduction in the risk of cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease with type 2 diabetes.

 

Kerendia is a first-in-class, orally administered, selective, nonsteroidal mineralocorticoid receptor antagonist (MRA) that has a novel mechanism that inhibits kidney inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes.

 

In addition, Kerendia has recently been shown to prevent heart failure-related secondary events in HF with mildly reduced ejection fraction (HFmrEF) and HF with preserved ejection fraction (HFpEF) with a left ventricular ejection fraction (LV ejection fraction) of 40% or greater and has entered into global Phase III trials.

 

The clinical trial to expand the indication to heart failure has also been approved in Korea.

 

Meanwhile, results from the Phase III FINEARTS-HF trial, which evaluated Kerendia in heart failure patients with left ventricular ejection fraction greater than 40%, were presented at the European Society of Cardiology Annual Congress 2024 (ESC 2024) in September.

 

Data from the Phase III FINEARTS-HF study showed that at a median follow-up of 32 months, there were a total of 1,083 worsening heart failure events in 624 of the 3003 patients in the Kerendia arm and a total of 1283 events in 719 of 2998 patients in the placebo arm.

 

The total number of worsening heart failure events was 842 in the Kerendia arm and 1024 in the placebo arm, with an 18% lower incidence rate in the Kerendia arm.

 

In addition, the proportion of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively, with a 7% lower hazard ratio observed in the Kerendia arm.

 

However, there was no significant difference between death from cardiovascular events and all-cause mortality.

 

According to drug research institution UBIST, prescriptions for Kerendia totaled KRW 1 billion in the first half of this year, and Bayer Korea is expected to expand the indications to further gain a competitive advantage.