Bayer submits marketing authorization applications for finerenone in the U.S. and the EU

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The FINANCIAL — Bayer announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated renal and cardiovascular benefits in patients with CKD and T2D in the Phase III FIDELIO-DKD study.

“Despite recent advances in treatment, many patients with chronic kidney disease and type 2 diabetes are still progressing to end-stage kidney failure or premature death,” said Professor George L. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of FIDELIO-DKD. “Finerenone works differently than current therapies and, if approved, provides a potential new treatment option to slow disease progression by directly targeting inflammation and fibrosis, major drivers of CKD progression.”

“With more than 160 million patients living with CKD and T2D, and the prevalence of T2D continuing to rise, CKD is a serious global health challenge that needs to be addressed,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “These submissions are an important step towards our aim to providing finerenone to patients soon. The findings from the FIDELIO-DKD study demonstrated the effects of finerenone in improving outcomes in these patients by delaying CKD progression and reducing the risk for cardiovascular events, and we look forward to working with the regulatory bodies to hopefully make this treatment available to patients as soon as possible.”

The marketing authorization application (MAA) submitted to the EMA and the new drug application (NDA) submitted to the U.S. FDA were based on positive data from the FIDELIO-DKD study, which is part of the largest Phase III clinical trial program to date in CKD and T2D. Results from the trial were presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020, and simultaneously published in the New England Journal of Medicine in October 2020.

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