Tag: finerenone

It’s Official – Finerenone is Approved for HF

Posted on by Jake Fishman

One of the hardest-to-treat cardiac conditions just got a little more hopeful as the FDA approved Bayer’s KERENDIA (finerenone) for treating heart failure patients with left ventricular ejection fraction ≥40%, marking the first new pharmaceutical option for HF in years.

  • KERENDIA is a non-steroidal mineralocorticoid receptor antagonist that blocks receptor overactivation in the heart and kidneys
  • The drug has been approved since July 2021 for chronic kidney disease associated with type 2 diabetes, with several studies examining its HF impacts since.

While not originally intended for HF, KERENDIA’s approval stems from the 6k patient Phase III FINEARTS-HF trial during which the drug demonstrated a 16% relative risk reduction in cardiovascular death and total HF events.

Follow-up sub-analyses also found that…

  • KERENDIA lowered the risk of CV events most in patients enrolled within one week (RR: 0.74) or three months of WHF (RR: 0.79).
  • The drug also significantly improved KCCQ from baseline by an average of 1.62 points at 12 months.
  • It also appears effective regardless of baseline bodyweight and reduces CV death and HF events across all BMI groups.

That’s exciting stuff from a drug that treats a disease it wasn’t designed for, but it still has some side effects worth noting when compared to placebo.

  • Main adverse reactions included hyperkalemia (9.7% vs 4.2% placebo), hypotension (7.6% vs 4.7%), hyponatremia (1.9% vs 0.9%), and worsening renal function events (18% vs 12%).
  • Nearly a quarter of finerenone patients experienced a ≥15% decline in eGFR compared to 13.4% on placebo. 
  • Notably, eGFR decline was associated with higher risk of CV death and HF events in patients on placebo but not in those on finerenone (aRR: 1.07 vs. 1.50).

The Takeaway

Bayer’s KERENDIA approval represents the first new treatment option specifically approved for an HF population that includes up to 3.7M people in the U.S. alone, and could become a core part of the comprehensive care these patients need.

Better Understanding Finerenone’s HF Impact

Posted on by Viktor Zarev

Finerenone (Bayer’s Kerendia) seems to be the gift that keeps on giving, and we can now add the ability to reduce worsening HF events in patients on diuresis to its growing list of benefits thanks to a new JAMA substudy of the FINEARTS-HF trial.

  • FINEARTS-HF explored the effects of finerenone in 6k HFmrEF/HFpEF patients and found that the drug significantly reduced worsening HF events and CV death versus placebo.
  • HF patients commonly face periods of stability interrupted by episodes of worsening symptoms and volume retention which causes physicians to put them on diuresis. 
  • Due to financial incentives and patient preference, oral diuretics tend to be more popular than intravenous loop diuretics because they don’t require in-patient care.

Diving deeper into the data from the FINEARTS-HF trial, researchers found that patients who were given more intense diuretic regimens (n=1,250) during worsening HF had nearly 3x higher death rates than those without worsening HF.

  • Patients on intense diuretic regimens faced a death rate of 11.6 per 100 patient-years compared with 4.5 per 100 patient-years for patients without worsening HF who didn’t need diuretics.

Where finerenone really shined was in reducing the death rate in patients on diuretics by cutting down on the need for more intense regimens.

  • Encouragingly, patients on finerenone saw an 11% decrease in diuretic intensification, meaning that finerenone helped avoid the need for intravenous loop diuretics. 
  • This contributed to a 15% reduction in the study’s overall composite endpoint of cardiovascular death, HF hospitalization, and urgent HF visits.

The Takeaway

We already know that finerenone is capable of reducing worsening HF and CV death, but understanding which symptoms it reduces can help us fine tune exactly which patients need it and when, especially as more research trickles in.

The Finer Points of FINEARTS-HF

Posted on by Viktor Zarev

Bayer’s FINEARTS-HF study revealed that finerenone could be poised to become the next big heart failure treatment at ESC 2024, and a new series of JACC sub-studies just further strengthened its case.

  • FINEARTS-HF explored the effects of finerenone in ~6k HFmrEF/HFpEF patients and found that the drug significantly reduced worsening HF events and CV death versus placebo.
  • Finerenone (Bayer’s Kerendia) got its start with CKD, and is the first mineralocorticoid receptor antagonist to be used for HF.

The first of the featured studies revealed that patients treated soon after experiencing a worsening heart failure (WHF) event saw greater benefits.

  • Finerenone lowered the risk of CV events most in patients enrolled within one week (RR: 0.74) or three months of WHF (RR: 0.79).

The second sub-study discovered that finerenone reduced HF events and improved patient health, regardless of baseline KCCQ score.

  • Finerenone reduced the risk of CV death and WHF events across all KCCQ ranges from scores of 0-<57 (RR: 0.82), to 57-<81 (0.88), and 81-100 (0.88). 
  • The drug also significantly improved KCCQ from baseline by an average of 1.62 points at 12 months.

Finerenone proved effective regardless of baseline bodyweight, reducing CV death and WHF events across all BMI groups (underweight/normal, rate ratio: 0.80; overweight: 0.91; obesity class I: 0.92; obesity class II-III: 0.67).

Despite the strong benefits, finerenone was not without its side effects, as the fourth and fifth sub-studies found that the drug led to a mild initial decline in eGFR, although it wasn’t significant enough to warrant stopping treatment. 

  • Nearly a quarter of finerenone patients experienced a ≥15% decline in eGFR compared to 13.4% on placebo. 
  • Notably, eGFR decline was associated with higher risk of CV death and HF events in patients on placebo but not in those on finerenone (aRR: 1.07 vs. 1.50). 

The Takeaway

After an impressive primary study and several supportive sub-studies, all signs seem to be pointing in the direction of finerenone as a frontline HF treatment. That’s pretty big considering how relatively empty the HF pharmaceutical space was a decade ago.

Finerenone’s Early Heart Failure Impact

Posted on by Jake Fishman

The FINEARTS-HF trial already showed that Bayer’s nsMRA finerenone (Kerendia) has the potential to slash mortality and event rates in HFpEF and HFmrEF patients, and new analysis suggests that its impact could be even greater if used earlier.

  • Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), blocking the mineralocorticoid receptor and its blood pressure effects.
  • Finerenone is already approved to reduce cardiovascular and kidney disease risks in patients with type 2 diabetes-associated CKD, but not for HF.

The original FINEARTS-HF trial presented at ESC 2024 saw finerenone drive a 16% reduction in cardiovascular death and HF events over 32 months, while the new analysis suggests that finerenone’s benefits are greatest if started shortly after patients experience a worsening heart failure event.

  • Compared to placebo, patients who received finerenone within 7 days of a WHF event saw their risk of future WHF events cut by 26%.
  • Patients treated between 7 days and 3 months after a WHF event saw risks of further WHF events lowered by 21%.
  • However, patients who were enrolled over 3 months after a WHF event or without prior WHF showed no changes in future WHF event risks.

Patients treated within 7 days of a WHF event also tended to achieve lower systolic blood pressure, lower EF, higher NT-proBNP, and worse NYHA functional class.

  • Notably, the study found no increased risk of hyperkalemia or worsening renal function among finerenone users with recent WHF, a big change versus the entire study group which had an increased risk of hyperkalemia. 

This looks like more good news for Bayer, which has made huge research investments to establish finerenone’s role across an even wider spectrum of HF patients, and forecasts that finerenone’s revenue could jump from $295M in 2023 to $3.3B in the future.

The Takeaway

Although this dataset wasn’t large enough to confirm a definitive treatment-by-time interaction, it certainly suggests that finerenone might have its greatest impact shortly after patients heart failure begins to worsen. And with a new drug, knowing which patients to target is a good way to start.

Bayer’s Kerendia Could Become First nsMRA Heart Failure Treatment

Posted on by Jake Fishman

Bayer’s nsMRA finerenone (Kerendia) might be on track to becoming a key heart failure treatment, after topline results from the FINEARTS-HF trial showed that finerenone significantly reduces cardiovascular death and HF events among patients with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).

  • Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), blocking the mineralocorticoid receptor and its blood pressure effects.
  • Finerenone is already approved to reduce cardiovascular and kidney disease risks in patients with type 2 diabetes-associated CKD, but not for HF. 

The Phase III FINEARTS-HF trial gave roughly 6,000 patients with HFmrEF or HFpEF (and LVEF ≥40%) either daily finerenone or a placebo, plus standard-of-care. After 42 months…

  • Finerenone drove a significant reduction in cardiovascular death and total HF events , achieving the primary endpoint. 
  • The trial didn’t expose any new safety signals beyond issues seen in finerenone’s  previous studies, which included a risk of hyperkalemia.

Even without publicizing the FINEARTS-HF data, confirmation of its “statistically significant” and “clinically meaningful” impact was enough to earn applause across #CardioTwitter, with many suggesting that finerenone might become the first nsMRA heart failure treatment.

  • If that happens, nsMRAs would join a quickly-evolving panel of HFpEF treatments, which first added SGLT2is just a few years ago and could add GLP-1s by next year.

Given nsMRAs’ potential to become a leading HF treatment, and the lack of current options for many HF patients, Bayer is all-in on finerenone.

  • The FINEARTS-HF study is part of Bayer’s massive 15k-patient MOONRAKER program, which could establish finerenone’s role across an even wider spectrum of HF patients.
  • Add those potential HF treatments with finerenone’s current CKD-based indication, and Bayer forecasts that finerenone’s revenue could jump from $295M in 2023 to $3.3B in the future.

The Takeaway

There’s still a lot we don’t know about the FINEARTS-HF trial, but this topline announcement suggests that finerenone could be on track to be the first nsMRA heart failure treatment. That would be a big deal for the millions of patients with HFmrEF and HFpEF, and for Bayer who could have a blockbuster on its hands.

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