Bayer's Kerendia cuts cardio death risk by 16% in hard-to-treat heart failure patients

At the European Society of Cardiology conference in London, Bayer unveiled promising results for its drug Kerendia, showing a significant reduction in cardiovascular death risk among heart failure patients with an ejection fraction above 40%. This development comes as heart failure cases continue to rise, making the timing ideal for Bayer's drug.

Kerendia, a nonsteroidal mineralocorticoid receptor antagonist (MRA), was initially approved three years ago for treating chronic kidney disease associated with Type 2 diabetes. However, its broader market potential lies in its efficacy against heart failure. Recently, Bayer announced a win in the Phase 3 FINEARTS-HF trial, highlighting that Kerendia reduced cardiovascular death risk by 16% compared to a placebo in patients with mildly reduced or preserved ejection fraction.

Kerendia is the first nonsteroidal MRA to achieve a primary composite cardiovascular endpoint in a phase 3 trial involving heart failure patients with a left ventricular ejection fraction (LVEF) of over 40%. The encouraging data was also published in The New England Journal of Medicine. According to Alanna Morris, senior medical director of U.S. medical affairs at Bayer, these findings are particularly significant given the limited medications available that show a definitive therapeutic benefit for patients with mildly reduced or preserved ejection fraction. She believes the results offer new insights for healthcare teams and patients, especially given the reduction in critical endpoints like death and hospitalization, along with improvements in patient-reported symptoms.

In the trial, which involved 6,001 patients on standard-of-care treatment, various measures between the finerenone and placebo groups were comparable. Serious adverse events were reported at 39% for finerenone and 41% for the placebo group. Treatment discontinuation rates (excluding deaths) were 20.4% for finerenone and 20.6% for placebo. Although hyperkalemia—an elevated potassium level—was more common in the finerenone group (10% versus 4%), it led to hospitalization in just 0.5% of patients on finerenone compared to 0.2% on the placebo.

The primary endpoint results were consistent across all prespecified subgroups. Notably, patients already on an SGLT2 inhibitor—currently the only treatment with a strong guideline recommendation for this population—experienced the same positive outcomes as those not on this medication. Morris pointed out that finerenone's different mechanism in the body likely explains its consistent efficacy, irrespective of the patients' existing treatment regimens.

Kerendia also showed positive outcomes in patients with an ejection fraction both greater and less than 60%. Since its market introduction, Kerendia's sales have grown significantly, reaching 200 million euros ($221 million) in the first half of the year, representing a 70% year-over-year increase. However, for Bayer to achieve its ambitious $3 billion annual sales target for Kerendia, the drug must become a dominant player in the heart failure market. GlobalData forecasts the total heart failure market to hit $53 billion by 2032.

Currently available SGLT2 inhibitors for heart failure include Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin), AstraZeneca and Bristol Myers Squibb’s Farxiga (dapagliflozin), and Lexicon Pharmaceuticals' Inpefa (sotagliflozin). In addition to Kerendia, other treatments in development with new mechanisms of action include Novo Nordisk’s GLP-1 semaglutide and Eli Lilly’s GLP-1/GIP tirzepatide.

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