Bayer Korea's Kerendia (ingredient: finerenone), a novel non-steroidal mineralocorticoid receptor antagonist (MRA), is garnering significant attention from local physicians as a potential game-changer in the treatment of chronic kidney disease (CKD) associated with type 2 diabetes.

The drug, which targets inflammation and fibrosis in the kidneys, represents a departure from the traditional focus on hemodynamic and metabolic factors in CKD management. The drug received reimbursement on Feb. 1.

"This drug represents an important therapeutic option for managing chronic kidney disease in diabetic patients," said Professor Lee Yong-ho, Secretary-General of the Korean Diabetes Association and an endocrinologist at Severance Hospital, during a press conference held by Bayer Korea to celebrate the drug's reimbursement on Friday. "Existing treatments have been focused on controlling blood pressure with renin-angiotensin system (RAS) inhibitors and improving metabolism with SGLT-2 inhibitors."

Despite these treatments, there remained a residual risk of CKD progression, and Kerendia, by targeting kidney inflammation and fibrosis, can further reduce the risk of CKD progression, Lee added.

Kerendia's insurance eligibility applies to patients who are already on the maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) but still have significant levels of albuminuria or reduced estimated glomerular filtration rates (eGFR).

This decision is backed by the extensive clinical trials FIDELIO-DKD and FIGARO-DKD, and their pooled analysis, FIDELITY-DKD, which demonstrated Kerendia's efficacy in reducing risks of kidney and cardiovascular outcomes by 23 percent and 14 percent, respectively.

"The findings from the FIDELITY-DKD study have led to Kerendia being recommended in national and international guidelines for the optimal reduction of CKD progression risk," Professor Kim Sung-kyun, Secretary-General of the Korean Society of Nephrology and a nephrologist at Hallym University Sacred Heart Hospital, said. "The guidelines have specifically mentioned Kerendia for its ability to reduce proteinuria by more than 30 percent, addressing a significant unmet need in CKD management."

"The results showed a 23 percent reduction in kidney composite outcomes and a 14 percent reduction in cardiovascular outcomes, making Kerendia a cornerstone in the treatment guidelines both domestically and internationally."

However, the use of Kerendia may be cautious due to concerns about hyperkalemia, a potential side effect.

Addressing such concerns, experts urged not to hesitate in prescribing Kerendia due to this, emphasizing that hyperkalemia can be managed effectively with interventions such as potassium binders.

"Hyperkalemia concerns should not deter using Kerendia," Kim said. "Like RAS inhibitors, it may induce hyperkalemia, but it is manageable. The guidelines recommend continuing treatment despite the occurrence of hyperkalemia."

Looking ahead, the potential for Kerendia to be used with SGLT-2 inhibitors offers further hope for comprehensive management strategies for patients with and without diabetes.

"Combining Kerendia with SGLT-2 inhibitors could provide additional benefits due to their different mechanisms of action," Kim speculated. "We eagerly await the outcomes of ongoing clinical trials exploring this combination therapy."

The inclusion of Kerendia in health insurance coverage is expected to expand treatment options for patients with diabetic kidney disease in Korea, potentially overcoming the unmet needs in CKD treatment, he added.