FDA Expands Kerendia Label to Type 1 Diabetes Chronic Kidney Disease

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Bayer announced that the FDA has approved a label expansion for its kidney disease drug Kerendia, also known as finerenone, to treat adults with chronic kidney disease associated with type one diabetes. The drug, a selective non-steroidal mineralocorticoid receptor antagonist, was initially approved in the United States in 2021 for chronic kidney disease associated with type two diabetes, and its label was expanded in 2025 to include adults with symptomatic chronic heart failure with a left ventricular ejection fraction of at least 40 percent. This latest approval, the drug's third in the United States, follows a Priority Review designation and is supported by positive results from the pivotal phase three FINE-ONE study, in which Kerendia added to standard of care produced a statistically significant 25 percent reduction from baseline in the urine albumin-to-creatinine ratio over six months compared with placebo. The company said the expanded indication addresses an important unmet need, as approximately 30 percent of people with type one diabetes in the United States develop chronic kidney disease. Kerendia, marketed as Firialta in some countries, is approved for chronic kidney disease associated with type two diabetes in China, Europe and Japan, and finerenone is also approved for heart failure with a left ventricular ejection fraction of at least 40 percent in Europe, Japan, China and several other markets. Year to date, Bayer's shares have risen 29.8 percent compared with the industry's 10.9 percent growth, and sales of Kerendia skyrocketed 82.9 percent in the second quarter.

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FDA approved label expansion of Bayer's Kerendia for chronic kidney disease in type 1 diabetes, its third US approval.

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