Bayer’s Kerendia was approved in 2021 to treat patients with chronic kidney disease (CKD) associated with Type 2 diabetes. For the nonsteroidal mineralocorticoid receptor antagonist (nsMRA) to accomplish the company’s gaudy sales target however, it will have to show its chops in heart failure (HF).
Chalk up a win for Kerendia in the phase 3 FINEARTS-HF trial, where it has shown it can reduce the risk of cardiovascular death, as well as first and recurrent HF events, compared to placebo plus standard of care in patients with mildly reduced or preserved ejection fraction.
The study included roughly 6,000 patients who have been diagnosed with symptomatic HF with a left ventricle ejection fraction (LVEF) greater than 40%, which accounts for about half of those with the condition. The patients received a daily dose of Kerendia or placebo for up to 42 months.
Without putting numbers to the claim, Bayer said that the trial met its primary endpoint, reaching statistically significant and clinically meaningful reductions in a composite total of cardiovascular death and HF events—defined by hospitalizations or urgent HF visits.
Bayer said it will present the data at the European Society of Cardiology (ESC) Congress, which starts late this month in London. It also will discuss the data with health authorities to prepare the submission of applications for marketing authorization.
“With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and the clinical community,” Christian Rommel, Ph.D., the R&D chief of Bayer’s Pharma Division, said in a release.
HF is a chronic condition characterized by the progressive decline in the ability of the heart to fill with and pump enough to supply the body’s needs for blood and oxygen. It affects more than 60 million people worldwide and is the leading cause of hospitalization for people older than age 65. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.
Bayer is making a big bet on Kerendia. Last year, it said it was planning three additional HF trials that would include roughly 9,000 participants. The trials are testing Kerendia in patients with the three classifications of the disorder—HF with reduced ejection fraction (HFrEF), which includes those with an LVEF of less than 40%; HF with mildly reduced ejection fraction (HFmrEF), which includes those with an LVEF between 41% and 49%; and HF with preserved ejection fraction (HFpEF), which includes those with a VLEF above 50%.
Kerendia sales were at 85 million euros in the first quarter, which was a 64% increase year over year. The company will report is second-quarter sales later this week.
Bayer has projected peak sales potential of Kerendia at 3 billion euros ($3.3 billion). GlobalData has projected Kerendia’s sales to reach $1.7 billion euros ($1.9 billion) in 2029.
Novo Nordisk hoped to bring a second nsMRA drug to the market with a $1.3 billion purchase of ocedurenenone from KBP Biosciences. But six weeks ago, Novo reported that ocedurenenone had flunked a phase 3 trial in systolic blood pressure.