New CKD drug Kerendia is reimbursed in Korea

‘'A New Path to Kidney Disease Treatment'

Will be reimbursed as a treatment for patients with chronic kidney disease with Type 2 Diabetes from February 1st

Demonstrated cardiovascular benefits and reduced albuminuria levels in 2 trials

"Despite the availability of diabetes, blood pressure meds, residual risk of kidney disease remain high… Kerendia’s use will continue to increase”

Sunggyun Kim, Professor at Hallym University Sacred Heart Hospital (Secretary-General, The Korean Society of Nephrology)

Whether the reimbursement coverage of Bayer’s Kerendia will help address the unmet needs of patients with chronic kidney disease with type 2 diabetes, is gaining attention.

 

Until now, blood pressure medications and diabetes drugs have been used to treat chronic kidney disease, but the introduction of Kerendia has expanded the treatment options.

 

Supported by its proven clinical efficacy, the drug is expected to be more widely used by patients with chronic kidney disease.

 

On the 15th, Bayer Korea held a press conference to celebrate the launch of Kerendia (finerenone) for chronic kidney disease with type 2 diabetes in Korea.

 

Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that has a novel mechanism of action that inhibits the overactivation of mineralocorticoid receptors, which can cause inflammation and fibrosis in the kidneys and blood vessels.

 

Overactivation of mineralocorticoid receptors causes inflammation and fibrosis in the kidneys, which can lead to deterioration of kidney function and cardiovascular disease.

 

The drug was granted reimbursement in combination with ACE inhibitors and ARBs for adult patients with type 2 diabetes who have been taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for at least 4 weeks but ▲have an albumin-to-creatinine ratio (uACR) >300 mg/g or a positive urine dipstick test (1+), or ▲have an estimated glomerular filtration rate (eGFR) of at least 25 but less than 75.

 

Kerendia’s reimbursement approval was based on the reduction in kidney disease progression, cardiovascular benefit, and safety that was demonstrated through the Phase III trials FIDELIO-DKD and FIGARO-DKD.

 

The FIDELIO-DKD study evaluated the safety and efficacy of Kerendia compared with placebo in 13,171 adult patients with type 2 diabetes in 48 countries.

 

Over a median follow-up of 3 years, Kerendia reduced the composite cardiovascular endpoint (cardiovascular death, nonfatal myocardial infarction, and stroke, etc) by 14%, and the renal composite endpoint (occurrence of a sustained decline in eGFR below 15 Ml for at least 4 weeks, chronic dialysis, and kidney transplantation) by 23%.

 

Results were consistent with and without treatment with GLP-1 receptor agonists and SGLT-2 inhibitors at baseline.

 

Kerendia also demonstrated significant risk reduction in the cardiovascular composite endpoint in the FIGARO-DKD study, which included patients with Stage I and II chronic kidney disease.

 

Yong-Ho Lee, Professor of Endocrinology and Metabolism at Severance Hospital (Secretary General, Korean Diabetes Association), said, “We have been using GLP-1 receptor agonists, SGLT-2 inhibitors, and blood pressure medications on chronic disease patients with diabetes, but there always remained a residual risk of chronic kidney disease in the patients.

 

SGLT-2 inhibitors do not completely reduce proteinuria, but Kerendia's efficacy, which was demonstrated through multiple clinical trials, makes the drug an important treatment option for patients with chronic kidney disease.” Sunggyun Kim, Professor at Hallym University Sacred Heart Hospital (Secretary-General, The Korean Society of Nephrology), said, “ The American Diabetes Association guidelines recommend a reduction in uACR of at least 30%, and Kerendia reduced the average uACR by 32% compared to placebo in the first 4 months of treatment.

 

Therefore, the drug can be considered in priority for patients with kidney disease."