Kerendia granted expanded indication in China to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study.- Bayer.
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.
“Early intervention in chronic kidney disease is essential to delay disease progression,” said Professor Zhu Dalong, Department of Endocrinology, Nanjing Drum Tower Hospital, Nanjing Medical School, China. “Chronic Kidney Disease is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. People with type 2 diabetes should have their urine tested regularly for albumin by a doctor and once diagnosed should be treated comprehensively to reduce the risk of cardiovascular complications and death. The Phase III FIGARO-DKD study included patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D. The label extension for Kerendia provides clinicians and patients with an effective option for early treatment.”
Mineralocorticoid receptor (MR) overactivation contributes to CKD progression and CV damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Addressing an alternative pathway, Kerendia offers protection as it selectively binds to the MR receptor, blocking harmful effects of MR overactivation.
Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted initial marketing authorization by the Chinese National Medical Products Administration (NMPA) in June 2022 for the treatment of CKD (eGFR of greater than 25 to 75 mL/min/1.73 m2 with albuminuria) associated with type 2 diabetes in adults, to reduce the risk of sustained eGFR decline and end-stage kidney disease. The label extension for Kerendia to include earlier stages of chronic kidney disease associated with type 2 diabetes and reduce patient’s risk of cardiovascular outcomes now reflects data from more than 13,000 patients with CKD and T2D, based on both the Phase III FIDELIO-DKD and FIGARO-DKD studies.
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