Bayer's Kerendia reduces cardio death and heart failure risk

Bayer's drug Kerendia has demonstrated significant efficacy in a phase 3 clinical trial involving patients with heart failure, revealing that the daily medication can lower the risk of cardiovascular death and heart failure incidents.

Initially approved in 2021 for treating chronic kidney disease (CKD) in patients with Type 2 diabetes, Kerendia has now proven its potential in heart failure (HF) treatment. This success was highlighted in the phase 3 FINEARTS-HF trial, where Kerendia was shown to reduce the likelihood of cardiovascular death and both first-time and recurring HF events when compared to a placebo plus standard care. The study focused on approximately 6,000 patients diagnosed with symptomatic HF with a left ventricle ejection fraction (LVEF) greater than 40%, which represents about half of all heart failure cases. Participants received either Kerendia or a placebo daily for up to 42 months.

While Bayer did not disclose specific numerical outcomes, the company stated that the trial's primary endpoint was achieved, with statistically significant and clinically meaningful reductions in the composite total of cardiovascular death and HF events, which include hospitalizations or urgent HF visits. The full results of the trial will be presented at the European Society of Cardiology (ESC) Congress in London later this month. Bayer also intends to discuss the data with health authorities to prepare for marketing authorization applications.

Christian Rommel, Ph.D., the head of Research and Development at Bayer’s Pharma Division, highlighted the significance of these findings, especially given the limited treatment options currently available for this common form of heart failure with mildly reduced or preserved ejection fraction. Rommel emphasized the importance of this development for both patients and the medical community.

Heart failure is a chronic condition marked by the heart's inability to adequately fill with and pump blood, affecting over 60 million people globally. It is the leading cause of hospitalization for individuals over 65 years old. Despite advancements in treatments, approximately 30% of heart failure patients die within one year of diagnosis, with the mortality rate increasing to around 40% within five years.

Bayer is placing substantial confidence in Kerendia, planning three additional heart failure trials involving about 9,000 participants. These trials will test Kerendia across the three classifications of the disorder: HF with reduced ejection fraction (HFrEF), HF with mildly reduced ejection fraction (HFmrEF), and HF with preserved ejection fraction (HFpEF).

In the first quarter of this year, Kerendia generated sales of 85 million euros, marking a 64% year-over-year increase. Bayer is set to announce its second-quarter sales figures later this week. The company has forecasted Kerendia’s peak sales potential to reach 3 billion euros ($3.3 billion).

In contrast, Novo Nordisk's attempt to introduce a second nsMRA drug to the market faltered. After acquiring ocedurenenone from KBP Biosciences for $1.3 billion, Novo Nordisk recently announced that the drug failed a phase 3 trial aimed at addressing systolic blood pressure.

By successfully targeting both chronic kidney disease and heart failure, Kerendia positions itself as a pivotal medication in Bayer’s portfolio, potentially reshaping treatment paradigms for these severe health conditions.

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