Key Takeaways
Bayer AG on Thursday secured a Priority Review designation from the U.S. Food and Drug Administration for its drug Kerendia, aiming to expand its use to adults with chronic kidney disease and type 1 diabetes after a trial showed a 25% kidney benefit.
"The FDA’s acceptance of this application underscores the clinical importance of our ongoing program for KERENDIA, and growing evidence base, across broad patient populations in cardiovascular and kidney diseases,” said Carolina Aldworth, Executive Medical Director at Bayer.
The supplemental New Drug Application (sNDA) is supported by the 242-patient FINE-ONE Phase III study. The trial met its primary endpoint by showing finerenone reduced the urine albumin-to-creatinine ratio (UACR), a key marker of kidney disease progression, by a least-squares mean of 25% over six months compared to placebo (p<0.001).
A priority review shortens the FDA's evaluation timeline, potentially accelerating the arrival of the first mineralocorticoid receptor antagonist (MRA) for the 20-30% of U.S. type 1 diabetes patients who also have chronic kidney disease. The successful trial is the first in this specific patient group since the 1990s.
The safety profile in the FINE-ONE trial was largely consistent with Kerendia's known profile in type 2 diabetes patients. Hyperkalemia, or high potassium levels, was observed more frequently with finerenone (10.1%) compared to placebo (3.3%), leading to a 1.7% treatment discontinuation rate for the drug.
Kerendia, known generically as finerenone, is already a key drug for Bayer. It was first approved in 2021 to treat chronic kidney disease associated with type 2 diabetes and later approved in 2025 for certain types of heart failure, competing with drugs like AstraZeneca's Farxiga.
The label expansion, if approved, would open a new, much-needed treatment avenue and a new revenue stream for one of Bayer's key pharmaceutical assets. Investors will now watch for the FDA's final decision, expected within the six-month priority review window.
This article is for informational purposes only and does not constitute investment advice.
