FDA approves Bayer's Kerendia for type 1 diabetes kidney disease

Bayer announced on 17 September 2026 that the U.S. Food and Drug Administration approved a label expansion for its kidney disease drug Kerendia (finerenone). The selective, non-steroidal mineralocorticoid receptor antagonist is now indicated for adult patients with chronic kidney disease associated with type 1 diabetes.

The approval was granted under FDA Priority Review and rests on the phase III FINE-ONE clinical trial. In the study, Kerendia added to standard of care produced a statistically significant 25% reduction from baseline in the urine albumin-to-creatinine ratio over six months compared with placebo. About 30% of people with type 1 diabetes in the United States develop chronic kidney disease, creating elevated risks of kidney failure.

This decision marks Kerendia's third approved indication in the United States. The drug was initially cleared in 2021 for chronic kidney disease linked to type 2 diabetes, and its label was broadened in 2025 for symptomatic chronic heart failure with a left ventricular ejection fraction of at least 40%. Bayer also markets the therapy as Firialta in select countries, while applications for non-diabetic chronic kidney disease remain under review in China and Japan.

Kerendia has become a core growth driver for Bayer, with sales jumping 82.9% in the second quarter on strong volumes in the United States and China. Alongside Nubeqa, it has helped offset patent-related revenue drops from Eylea, partnered with Regeneron, and Xarelto, partnered with Johnson & Johnson. Bayer shares have risen 29.8% year to date, outpacing the broader industry's 10.9% advance.