Bayer's near-approval Farxiga rival meets goal in 2nd phase 3

Bayer’s finerenone has met the primary endpoint in another phase 3 clinical trial. The study, which linked the mineralocorticoid receptor antagonist to a significant reduction over placebo against a composite cardiovascular event endpoint, has met the primary endpoint in another phase 3 clinical trial.

Last year, Bayer presented data from a phase 3 trial that tested finerenone in patients with Type 2 diabetes and chronic kidney disease. Bayer went on to file for FDA approval using the data, although unfavorable cross-trial comparisons with SGLT2 inhibitors such as AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana left unanswered questions about its commercial prospects.

The latest update, which comes from a clinical trial that enrolled more patients with earlier-stage disease than the previous study, provides further evidence that finerenone works without answering the question of whether it works well enough to be a major product.

Finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular death or nonfatal myocardial infarction, stroke or hospitalization for heart failure. The result meant the trial hit its primary endpoint, but Bayer is yet to share the numbers that will influence whether finerenone is a commercial success.

Bayer plans to share data from the study at an upcoming scientific meeting. For now, Bayer has only revealed that the trial met its primary endpoint. The study randomized 7,400 people to take placebo or one of two doses of finerenone orally once daily on top of standard of care.

The FDA granted priority review to finerenone in January, teeing the agency up to make a decision in the coming months. If approved, finerenone will enter a market already fought over by products such as Farxiga and Invokana. 

The effect of SGLT2 inhibitors on cardiovascular disease outcomes became clear after Bayer began its late-stage work, which it described as the “largest phase III clinical trial program to date focusing on chronic kidney disease and type 2 diabetes across a broad range of disease severity.” The success of the SGLT2 inhibitors raised the bar for finerenone.