U.S. FDA Accepts New Drug Application and Grants Priority Review for Finerenone for Patients with Chronic Kidney Disease and Type 2 Diabetes

Submission based on Phase III FIDELIO-DKD trial data (n=5734), which showed that treatment with finerenone resulted in lower risk of CKD progression vs placebo (40% baseline reduction eGFR or death from renal causes in (17.8% vs 21.1%; HR 0.82; 95% CI, 0.73 to 0.93; P=0.001).

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Biospace Inc.