With the late-stage win, Bayer announced Monday that it plans to talk to regulators about seeking approval in an indication that is central to its $3 billion-plus peak sales forecast.
Bayer said Monday its Phase III cardiovascular outcomes trial hit the primary endpoint, positioning the company to discuss with regulators filing for approval of finerenone in heart failure.
The FDA approved finerenone in adults with chronic kidney disease associated with type 2 diabetes in 2021. Bayer, which sells the drug as Kerendia in the kidney indication, also identified the potential for the non-steroidal, selective mineralocorticoid receptor antagonist to improve outcomes in people with heart failure with mildly reduced or preserved ejection fraction.
Bayer put that idea to the test in the FINEARTS-HF study. Investigators randomized around 6,000 people with symptomatic heart failure to take finerenone or placebo once a day for up to 42 months. Monday, Bayer said finerenone significantly reduced the composite of cardiovascular death and total heart failure events compared to placebo.
The significant reduction caused the trial to hit its primary endpoint. Bayer is yet to share data from the study but is sufficiently encouraged by the results to outline plans to talk to regulatory agencies about filing for approval.
Finerenone was well tolerated in the study, according to Bayer. While the company did not share data on safety and tolerability, the positive topline finding is encouraging for a molecule with a mechanism of action that has proven problematic in the past.
Mineralocorticoid receptor antagonists such as spironolactone and eplerenone are used to treat heart failure with reduced ejection fraction. In that population, the drugs have improved outcomes in clinical trials. However, spironolactone was less impressive in a trial in heart failure with preserved ejection fraction, failing to reduce cardiovascular mortality while raising the risk of elevated potassium levels.
Bayer’s trial program, which has enrolled more than 15,000 patients, and real-world finerenone use in kidney disease patients suggest the risk of elevated potassium levels may be lower for its molecule. The combination of improved cardiovascular outcomes and acceptable tolerability underpins Bayer’s hopes of turning finerenone into a blockbuster.
The company is targeting peak sales of more than 3 billion euros ($3.3 billion). Bayer has retained the sales target even as Kerendia has made a slow start in kidney disease. Talking on an earnings call in May, Stefan Oelrich, head of Bayer’s pharmaceuticals unit, said “I think we’ve all been a little underwhelmed with the development of the renal market.”
Oelrich said the market is “definitely not progressing at a speed that we had wished for” but predicted heart failure “will ultimately ... allow us to get to peak sales.” Finerenone is one of a clutch of key growth products at Bayer. The drugmaker shared positive Phase III data on another key product, prostate cancer drug Nubeqa, in July.
