Bayer files finerenone in EU for heart failure

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Kerendia pill bottle with tablets on surface

Bayer has filed its mineralocorticoid receptor antagonist (MRA) finerenone as a treatment for a common form of heart failure in the EU, fulfilling a key 2025 pipeline objective.

The pharma group has filed finerenone for use in heart failure patients with mildly reduced or preserved left ventricular ejection fraction – HfmrEF or HFpEF – on top of standard heart failure therapies. It previously filed the drug for this use in the US and China.

The submission follows positive data in the 6,000-patient FINEARTS-HF trial, which was presented at last year's ESC Congress and showed that Kerendia reduced the risk of the composite primary endpoint of cardiovascular death and hospitalisations or urgent visits for heart failure by 16% compared to placebo over a median follow-up of 32 months.

The study enrolled people with a left ventricular ejection fraction of 40% or more, a group that accounts for around half of the 15 million people in the EU living with heart failure and 60 million people worldwide.

"Treating heart failure with an LVEF of 40% or greater poses unique challenges, leaving patients with few effective therapeutic options," said Christine Roth, head of global product strategy and commercialisation at Bayer.

"If approved, finerenone has the potential to become a new pillar in addressing this common form of heart failure, offering hope for improved outcomes in a patient population that has long been underserved," she added.

Finerenone is already on the market as Kerendia (and Firialta in some markets) for chronic kidney disease associated with type 2 diabetes, but expanding its label to include heart failure is a key component of Bayer's plan to grow the drug into a $3 billion-plus product.

That's a big ask for the drug, given that sales of Kerendia were around $333 million in the first nine months of 2024 and it will have to compete with other add-on therapies that are used in people with HFmrEF and HFpEF. That includes AstraZeneca's Farxiga (dapagliflozin) and Eli Lilly/Boehringer Ingelheim's Jardiance (empagliflozin) – both SGLT2 inhibitor – and Novartis' Entresto (sacubitril/valsartan).

It's worth noting that around 14% of patients in FINEARTS-HF were already on an SGLT2 inhibitor, suggesting there could be a rationale for dual use of the drugs.

Bayer is running additional trials of finerenone in the hope of building a case for the MRA in heart failure, including CONFIRMATION-HF which is testing Kerendia with Jardiance in patients hospitalised or recently discharged with heart failure, regardless of their LVEF status.

It is also running the REDEFINE-HF trial as monotherapy in patients with an LVEF of 40% or more, and the FINALITY-HF study as a monotherapy in those with an LVEF below 40%.