Europe Approves First Targeted Heart Failure Treatment for Mr. Patients

The European Commission has approved finerenone for the treatment of adults with heart failure and a left ventricular ejection fraction of 40% or higher, marking the first targeted therapy authorized in Europe for this patient group.

The approval expands the use of finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist already indicated in Europe for chronic kidney disease associated with type 2 diabetes, to include heart failure with mildly reduced or preserved ejection fraction.

This decision is based on positive results from the Phase 3 Finearts-HF study, which evaluated the drug in approximately 6,000 patients with heart failure and left ventricular ejection fraction ≥40%, representing a broad range of clinical characteristics.

Finerenone has demonstrated statistically significant and clinically relevant cardiovascular benefits in this population, offering a new therapeutic option in an area where treatment needs remain largely unmet.

Heart failure continues to significantly impact the daily lives of millions of people in Europe, with repeated hospitalizations, debilitating symptoms such as shortness of breath and chronic fatigue, and an uncertain prognosis remaining common for many patients.

The arrival of a new treatment option helps address a therapeutic area that has seen more limited progress compared to other forms of heart failure, according to Bayer, which markets finerenone under the brand name Kerendia.

Simona Gatti, Medical Director of Bayer Pharma Italy, stated that the approval is excellent news for the millions of European patients with heart failure and ejection fraction ≥40%, emphasizing the company’s commitment to ensuring eligible patients can access this important new treatment to improve clinical outcomes.

Christine Roth, Executive Vice President of Global Product Strategy and Market Access at Bayer, echoed this sentiment, noting the approval is excellent news for millions of patients in Europe with heart failure and left ventricular ejection fraction of ≥40%, and reaffirming Bayer’s commitment to patient access and improved outcomes.

With this authorization, finerenone becomes the first drug targeting the mineralocorticoid receptor pathway to show statistically significant and clinically relevant cardiovascular benefits in a Phase 3 trial for adults with heart failure and preserved or mildly reduced ejection fraction.

The approval reflects ongoing efforts to expand treatment options for heart failure, a condition that affects over 60 million people globally and remains a leading cause of hospitalization and cardiovascular death.