Finerenone, an investigational agent from a new drug class, just scored a second pivotal trial win after showing significant benefit for slowing progression of diabetic kidney disease in patients with type 2 diabetes in the FIDELIO-DKD pivotal trial with more than 5,700 patients.
Top-line results from FIGARO-DKD showed significant benefit for the primary endpoint of cardiovascular death and nonfatal cardiovascular disease endpoints in a placebo-controlled trial with about 7,400 patients with type 2 diabetes, reported Bayer, the company developing finerenone in statement released on May 10, 2021.
Based on the FIDELIO-DKD results, finerenone is currently under review by the U.S. Food and Drug Administration for marketing approval as a treatment for patients with type 2 diabetes and chronic kidney disease. FIDELIO-DKD, in addition to the primary endpoint that focused on slowing progression of diabetic kidney disease, had a secondary endpoint that assessed the combined incidence on treatment of cardiovascular death, or nonfatal episodes of stroke, MI, or hospitalization for heart failure. Results from the study published in 2020 in the New England Journal of Medicine showed that finerenone was safe and effective for both endpoints.
In the current study, FIGARO-DKD, run at more than 1,000 sites in 47 countries, these endpoints flipped. The primary outcome was a composite of cardiovascular death or nonfatal cardiovascular disease events, and the secondary outcome was prevention of DKD progression.
Other than stating the results significantly fulfilled FIGARO-DKD’s primary endpoint of reducing the incidence of combined cardiovascular disease endpoints, the release gave no further outcome details. The release noted that the enrolled patient cohort in FIGARO-DKD included more patients with earlier-stage chronic kidney disease, compared with FIDELIO-DKD.
Finerenone is a first-in-class investigational nonsteroidal, selective mineralocorticoid receptor antagonist (MRA). As an MRA it shares certain activities with the steroidal MRAs spironolactone and eplerenone. But the absence of a steroidal structure means that finerenone does not cause steroidal adverse effects such as gynecomastia. Results in FIDELIO-DKD showed that finerenone caused more hyperkalemia than placebo, but the level of hyperkalemia that it causes relative to spironolactone or eplerenone remains uncertain.