Bayer submits application to the FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need.

Bayer announced the submission of marketing authorization applications to the FDA and to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval of finerenone in the U.S. and in China for adult patients with HF with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with this common form of HF in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia or, in some countries, as Firialta and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.

Heart failure (HF) affects over 60 million people worldwide and is a rapidly growing public health issue. Approximately half of these patients suffer from HF with a LVEF of ≥40%. HF with a LVEF ≥40% is associated with multiple comorbidities, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF.

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%.

The New Drug Applications submitted to the  FDA and to the CDE of China’s National Medical Products Administration are based on positive data from the FINEARTS-HF study, which is part of one of the largest Phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. 

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities. With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

“Heart failure represents a serious global health challenge, particularly for patients with a left ventricular ejection fraction of ≥40%, who are difficult to treat”, said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, finerenone could emerge as a new pillar of treatment for this common form of heart failure, offering the potential to improve cardiovascular outcomes for patients who currently have limited treatment options with proven efficacy.”