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.
