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Bayer applies in EU for extension of Indication to Finerenone
The submission is based on positive data from the FIGARO-DKD study, which demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. FIGARO-DKD included patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D.
Berlin: Bayer has submitted a Type II Variation application to the European Medicines Agency (EMA) to seek an extension of the finerenone marketing authorization to include early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D).The submission is based on positive data from the FIGARO-DKD study, which demonstrated that finerenone significantly reduced the risk...
Berlin: Bayer has submitted a Type II Variation application to the European Medicines Agency (EMA) to seek an extension of the finerenone marketing authorization to include early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
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