Bayer's Kerendia reduces heart-related death, failure, and hospitalization by 16% in Phase 3 trial

Bayer has recently detailed the successful results of its drug Kerendia in a subset of heart failure patients, following a late-phase trial. This development has prompted the company to consider a regulatory filing that could significantly enhance the drug's market potential.

Kerendia, a mineralocorticoid receptor antagonist, was initially approved by the FDA in 2021 to reduce the risk of certain kidney and heart events in patients with chronic kidney disease linked to type 2 diabetes. Bayer is now aiming to broaden the drug's application to a wider patient demographic.

In a Phase 3 trial, Kerendia demonstrated a 16% relative risk reduction in cardiovascular death and total heart failure events compared to a placebo over a median period of 32 months. This data was presented at the European Society of Cardiology annual meeting in London. Heart failure events were categorized as hospitalizations or urgent visits due to heart failure.

The FINEARTS-HF trial included over 6,000 participants with heart failure and a left ventricular ejection fraction (LVEF) of at least 40%. These patients also received standard-of-care treatment. While earlier announcements confirmed that the trial met its primary endpoint, detailed figures and p-values were not initially disclosed.

Heart failure affects more than 60 million individuals globally, with roughly half experiencing an LVEF of at least 40%. The 16% reduction in risk observed with Kerendia was consistent across all 17 pre-specified subgroups, including patients recently discharged from the hospital and those on SGLT2 inhibitors at baseline, according to Bayer’s senior global medical affairs physician Katja Rohwedder.

SGLT2 inhibitors like Eli Lilly and Boehringer Ingelheim’s Jardiance, as well as AstraZeneca’s Farxiga, are commonly used to treat heart failure. Kerendia’s ability to improve cardiac outcomes in patients already on these medications could position it as a crucial element of heart failure treatment, Rohwedder indicated.

Secondary endpoints of the trial revealed that Kerendia reduced total heart failure events and enhanced patient-reported health status from baseline, showing statistical significance in both cases.

Bayer plans to pursue a US label expansion for Kerendia soon. The drug's sales in the second quarter rose by 71% compared to the same period in 2023, amounting to €115 million ($127.7 million).

Data analysts previously projected that Kerendia could achieve sales of €1.7 billion ($1.9 billion) by 2029. Nevertheless, the journey to label expansion has faced challenges. In 2022, a pooled analysis from two Phase 3 trials indicated that Kerendia did not significantly lower all-cause or cardiovascular mortality in patients with diabetic kidney disease.

Despite these hurdles, heart failure remains a key focus for Bayer's long-term plans for Kerendia. To explore its full potential, Bayer has expanded its registrational heart failure program to include three additional studies. These studies will collectively enroll 9,000 patients to test Kerendia in individuals with reduced, mildly reduced, and preserved ejection fractions, respectively.

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