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.
