Bayer's Kerendia Secures FDA Approval for Expanded Heart Failure Treatment

Bayer's Kerendia (finerenone) has received FDA approval for an expanded label, marking a significant advancement in heart failure treatment options. The drug, a nonsteroidal selective mineralocorticoid receptor antagonist (MRA), is now indicated for patients with heart failure with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF).

Kerendia's New Indications and Mechanism of Action

The FDA's decision allows Kerendia to be prescribed for heart failure patients without chronic kidney disease (CKD) associated with type 2 diabetes, broadening its potential patient population. As an MRA, Kerendia functions as a diuretic, reducing sodium reabsorption in the kidneys and promoting water excretion. This mechanism leads to lower blood pressure and decreased fluid accumulation around the heart.

Dr. Alanna Morris-Simon, Bayer's senior medical director of U.S. medical affairs, explained, "When you have heart failure, there are different hormones that circulate in your blood that kind of mess up the way that your heart and your kidney talk to each other. A drug like Kerendia enables the heart and the kidneys to talk to each other in a much more efficient way by blocking one of those bad hormones."

Clinical Evidence and Market Implications

The label expansion was supported by the FINEARTS-HF phase 3 trial, which demonstrated a 16% reduction in the risk of cardiovascular death or heart failure events compared to placebo. Notably, the results were consistent across all prespecified subgroups, including patients already using SGLT2 inhibitors.

This approval positions Kerendia to compete with SGLT2 inhibitors like Eli Lilly and Boehringer Ingelheim's Jardiance and AstraZeneca's Farxiga, which have shown similar risk reductions in their respective trials. The SGLT2 inhibitor class has been a game-changer in heart failure treatment, with Jardiance and Farxiga generating sales of $12.4 billion and $7.7 billion, respectively, in 2024.

Bayer projects peak annual sales for Kerendia to reach $3 billion, reflecting the drug's potential impact on the market and the significant unmet need in heart failure treatment, particularly for HFpEF and HFmrEF patients.

Addressing Unmet Needs in Heart Failure Treatment

The approval of Kerendia for HFpEF and HFmrEF addresses a critical gap in heart failure management. These conditions have historically been challenging to treat, with numerous trial failures preceding the recent breakthroughs with SGLT2 inhibitors and now Kerendia.

Dr. Morris-Simon highlighted this challenge, stating, "Patients with heart failure with mildly reduced EF and heart failure with preserved EF historically have had very limited treatment options. We're excited that Kerendia really hopefully will provide a benefit for a very large patient population—larger than we've seen based on our current indication."

The difficulty in treating these forms of heart failure stems partly from diagnostic challenges and the ineffectiveness of therapies traditionally used for heart failure with reduced ejection fraction (HFrEF). The approval of Kerendia, along with recent advancements in SGLT2 inhibitors, represents a significant step forward in addressing these previously underserved patient populations.