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

Bayer's Kerendia, initially approved to minimize the risk of heart failure and cardiovascular issues in chronic kidney disease (CKD) patients with type 2 diabetes, has now gained an FDA approval to treat heart failure patients, irrespective of CKD presence. This marks a significant step forward in heart failure treatment, particularly for those with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF).

Previously, options for HFpEF and HFmrEF patients were limited, with treatments mainly successful in those with reduced ejection fraction (HFrEF). HFrEF indicates a heart muscle that doesn't contract effectively, making it easier for medications to target. On the other hand, HFpEF and HFmrEF involve the heart muscle contracting properly but having trouble relaxing, which has presented challenges in developing effective treatments.

Historically, SGLT2 inhibitors, such as Eli Lilly and Boehringer Ingelheim's Jardiance and AstraZeneca's Farxiga, were the first to show substantial benefits for these more complex heart failure types. These medications were initially approved for type 2 diabetes and later extended to cover all heart failure categories, boosting their sales significantly. In 2024, their sales reached $12.4 billion and $7.7 billion, respectively.

Bayer now anticipates that Kerendia will achieve peak annual sales of $3 billion. As a nonsteroidal selective mineralocorticoid receptor antagonist (MRA), Kerendia acts as a diuretic, reducing sodium reabsorption in the kidneys. This process promotes increased water excretion, resulting in lower blood pressure and reduced fluid buildup around the heart.

According to Dr. Alanna Morris-Simon, Bayer’s senior medical director of U.S. medical affairs, Kerendia offers new hope for a large patient population previously underserved by existing therapies. The drug facilitates more efficient communication between the heart and kidneys by blocking detrimental hormones, thereby potentially improving heart failure management.

The approval expansion was supported by the FINEARTS-HF phase 3 trial. This study demonstrated a 16% reduction in the risk of cardiovascular death or heart failure events for those treated with Kerendia compared to a placebo, on top of standard care. These results are in line with findings from trials that led to expanded indications for medications like Jardiance and Farxiga.

A notable aspect of the FINEARTS-HF study was its consistency across all patient subgroups. Even those already on an SGLT2 inhibitor—the primary recommended treatment for this patient group—experienced similar positive outcomes, emphasizing Kerendia’s effectiveness.

This development has been crucial for the scientific community, which has struggled to adapt medications successful in HFrEF to the HFpEF and HFmrEF categories. Dr. Morris-Simon noted that recognizing heart failure in patients with preserved ejection fraction often takes more time, complicating treatment efforts.

The introduction of Kerendia adds a valuable tool for clinicians in treating heart failure, particularly for those patients who previously had limited options. By addressing the complex interactions between the heart and kidneys, Kerendia represents a promising advance in cardiovascular medicine, potentially improving outcomes for a broad range of heart failure patients.