Bayer's Kerendia Gains 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, originally approved for chronic kidney disease associated with type 2 diabetes, can now be used to treat patients with heart failure with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF).

Kerendia's New Role in Heart Failure Management

Kerendia, a nonsteroidal selective mineralocorticoid receptor antagonist (MRA), has demonstrated efficacy in addressing a critical gap in heart failure treatment. The FDA's decision allows for its use in patients who do not have chronic kidney disease linked to type 2 diabetes, broadening its potential impact.

Dr. Alanna Morris-Simon, Bayer's senior medical director of U.S. medical affairs, emphasized the significance of this approval: "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."

Clinical Evidence and Market Implications

The FINEARTS-HF phase 3 trial underpinned Kerendia's label expansion. The study showed a 16% reduction in the risk of cardiovascular death or heart failure events compared to placebo, with consistent results across all prespecified subgroups. Notably, patients already using SGLT2 inhibitors—the only other treatment with strong guideline recommendations for this population—saw similar benefits.

This expansion positions Kerendia alongside SGLT2 inhibitors like Eli Lilly and Boehringer Ingelheim's Jardiance and AstraZeneca's Farxiga in the heart failure treatment landscape. While these drugs have seen significant sales growth due to their expanded indications, Bayer projects peak annual sales for Kerendia to reach $3 billion.

Mechanism of Action and Treatment Challenges

Kerendia functions as a diuretic, decreasing sodium reabsorption in the kidneys and leading to lower blood pressure and reduced fluid around the heart. Dr. Morris-Simon explained its unique mechanism: "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."

The approval addresses a longstanding challenge in heart failure treatment. While managing heart failure with reduced ejection fraction (HFrEF) has been relatively straightforward, developing effective therapies for HFpEF and HFmrEF has proven difficult. After decades of trial failures, SGLT2 inhibitors were the first to show significant benefits in these more challenging indications, with Kerendia now joining their ranks.