Bayer Wins FDA Acceptance for KERENDIA CKD Filing Without Diabetes

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Bayer reported that the U.S. FDA accepted its supplemental New Drug Application for KERENDIA for chronic kidney disease patients without diabetes. The filing is backed by Phase III trial data that Bayer says showed kidney and cardiovascular benefits in non diabetic CKD patients, and KERENDIA is already approved in the U.S. for adults with chronic kidney disease associated with type 2 diabetes. The sNDA covers adults with CKD without diabetes on standard care, a population not included in KERENDIA's current U.S. approvals, and the FIND CKD trial enrolled 1,584 such patients and showed a statistically significant 0.7 mL/min/1.73 m²/year difference in eGFR decline versus placebo, plus a benefit on a kidney cardiovascular composite outcome. Bayer, a €41.8 billion life science group active across Europe, the Americas and Asia, has been pushing deeper into prescription therapies, and the company's narrative highlights new labels and approvals for KERENDIA as a key pharmaceutical catalyst that can help offset patent losses. The critical signpost now is the FDA's decision on this sNDA, including the timing and any label wording around the kidney and cardiovascular endpoints from FIND CKD.

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FDA accepted Bayer's sNDA for KERENDIA in non-diabetic CKD, advancing a key label expansion toward approval.

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