With the heart failure (HF) patient population rapidly expanding, the timing is right for Bayer’s Kerendia (finerenone). The nonsteroidal mineralocorticoid receptor antagonist (MRA) was approved three years ago for chronic kidney disease (CKD) associated with Type 2 diabetes, but the bulk of its market potential lies with its ability to treat HF.
Four weeks ago, the company revealed that it had scored a victory in the phase 3 FINEARTS-HF trial. Now, Bayer is putting numbers to the claim, unveiling data from the trial that showed Kerendia reduced the risk of cardiovascular death as well as well as first and recurrent HF events by 16% compared to placebo in patients with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF).
Kerendia is the first nonsteroidal MRA to meet a primary composite cardiovascular endpoint in a phase 3 trial investigating HF patients with a left ventricle ejection fraction (LVEF) of more than 40%, the company said.
Bayer presented the data at the European Society of Cardiology (ESC) event Sunday in London. The results also were published Sunday in The New England Journal of Medicine.
“It is important to remember that there have been very few medications that have demonstrated a definitive therapeutic benefit for patients with HFmrEF and HFpEF, so we believe these results provide new insights for health care teams and patients alike, especially given the reduction in clinical endpoints like death and hospitalization and improvements in patient-reported symptoms,” Alanna Morris, M.D., Bayer’s senior medical director of U.S. medical affairs, explained in an email.
Bayer said it plans to submit applications for marketing authorization for finerenone for HF with a LVEF of greater than 40% “in due course.”
In the trial of 6,001 patients, who also were on standard-of-care treatment, there were several comparable measures between the finerenone and placebo groups. Serious adverse events came in at 39% for finerenone and 41% for the control group. Patients who discontinued treatment—not because of death—were at 20.4% for finerenone and 20.6% for placebo.
While hyperkalemia—an elevated level of potassium—was more prevalent in the finerenone group, 10% versus 4%, it led to hospitalization in just 0.5% of those on the test side. with 0.2% on the placebo.
The results for the primary endpoint were consistent across all prespecified subgroups. It was particularly noteworthy that patients at baseline using an SGLT2 inhibitor—the only treatment option with a strong guideline recommendation in this population—saw the same primary outcome results as those not on one.
“This prespecified subgroup analysis showed that finerenone demonstrated positive outcomes regardless of a patients’ prescribed treatment regimen. This is likely because finerenone works differently in the body to reduce cardiovascular risk than other medications,” Morris said.
In another key subgroup breakdown, Kerendia showed equally positive outcomes in patients with an ejection fraction of greater and less than 60%.
Sales have scaled up for Kerendia since it hit the market, reaching (PDF) 200 million euros ($221 million) in the first half for a 70% year-over-year increase. But for it to realize the $3 billion annual sales potential Bayer has pegged for Kerendia, it will have to become a major player in HF. GlobalData forecasts the total market to reach $53 billion in 2032.
SGLT2 inhibitors on the market for HF are 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 that would bring a new mechanism of action to the indication include Novo Nordisk’s GLP-1 semaglutide and Eli Lilly’s GLP-1/GIP tirzepatide.