Bayer submits application in EU for extension of finerenone to include early stages of CKD associated with type-II diabetes
Regulatory submission is based on positive data from the pivotal phase-III FIGARO-DKD study, published in the 'New England Journal of Medicine,' which covers a broad range of disease severities of Chronic Kidney Disease (CKD) associated with type-II diabetes
Bayer has submitted a type-II variation application to the European Medicines Agency (EMA) to seek an extension of the finerenone marketing authorisation to include early stages of Chronic Kidney Disease (CKD) associated with type-II diabetes, the company said in a statement.
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 type-II diabetes. FIGARO-DKD included patients across a broad range of disease severity, including stages 1-4 CKD associated with type-II diabetes. Results from the trial were presented at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine. FIDELIO-DKD and FIGARO-DKD are part of the largest phase-III clinical trial programme to date in CKD and type-II diabetes which demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with type-II diabetes, said the statement.
“Many patients with CKD and type-II diabetes are progressing to kidney failure or premature death. Early diagnosis and treatment are important to reduce the high burden of cardiovascular and kidney events in these patients. The FIGARO-DKD study included patients with early stages of CKD and demonstrated cardiovascular benefits of finerenone across a wide range of disease severity,” said Dr Christian Rommel, Member, Executive Committee, Bayer AG’s Pharmaceutical Division and Head, Research and Development, in the statement.
The statement further said that based on the positive results of the FIDELIO-DKD phase-III study, in February 2022, finerenone was approved in the EU for adult patients with CKD (stage three and four with albuminuria) associated with type-II diabetes. In July 2021, finerenone was approved by the US Food and Drug Administration (FDA) to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalisation for heart failure in adult patients with CKD associated with type-II diabetes. Finerenone has also been submitted for marketing authorisation in multiple other countries worldwide and these applications are currently under review.
Kerendia is a non-steroidal, selective Mineralocorticoid Receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. In type-II diabetes, MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. The phase-III study programme with finerenone, Finepovate, currently comprises five phase-III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD and Fiona as well as the phase-II study Confidence, noted the statement.
Having randomised more than 13,000 patients with CKD and around the world, the phase-III programme with finerenone in CKD and type-II diabetes comprises two completed and published studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and type-II diabetes. FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D, it added.