Bayer’s Kerendia approved in US as first new CKD and type 1 diabetes therapy in three decades

The Food and Drug Administration (FDA) has approved Bayer’s Kerendia (finerenone) as the first new therapy in over three decades for chronic kidney disease (CKD) associated with type 1 diabetes (T1D).

The once-daily, oral, non-steroidal mineralocorticoid receptor antagonist (MRA) is indicated to reduce urinary albumin-to-creatinine ratio (UACR).

FDA’s approval is supported by data from three Phase III clinical trials: the FINE-ONE in adults with CKD associated with T1D, alongside the FIDELIO-DKD and FIGARO-DKD trials for CKD associated with type 2 diabetes (T2D).

Furthermore, Kerendia is approved to reduce the risk of several associated conditions in adults with CKD associated with T2D, including sustained eGFR decline, end-stage kidney disease and cardiovascular disorders. Additionally, the oral MRA is authorised to reduce the risk of cardiovascular issues in heart failure patients with left ventricular ejection fraction (HF LVEF) ≥40 percent.

“The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need”

Dr Janet McGill, Professor of Medicine at Washington University and Co-Chair of the FINE-ONE study’s Executive Committee

Dr Janet McGill, Professor of Medicine at Washington University and Co-Chair of the FINE-ONE Executive Committee, said: “The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”

Bayer’s Executive Medical Director, Dr Carolina Aldwort, added: “Kerendia’s third indication validates the breadth of its clinical trial programme across cardiovascular and kidney diseases, helping a patient population that has historically been clinically underserved.”

Detailed FINE-ONE trial results are available in the New England Journal of Medicine.

Earlier this year, the European Commission approved Sanofi’s biologic Teizeild (teplizumab) as the first disease-modifying treatment for type 1 diabetes in the EU.