Kerendia granted expanded indication in China for broad range of patients with chronic kidney disease and type 2 diabetes
Bayer announced that the Chinese National Medical Products Administration (NMPA) granted marketing authorization for a label extension for Kerendia (finerenone) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study
The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is now indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adult patients with CKD associated with T2D (with albuminuria).
Results from the pivotal Phase III FIGARO-DKD study were presented at the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in the New England Journal of Medicine (previously cited). FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD and T2D. The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D versus placebo.
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