𝗨.𝗦. 𝗙𝗗𝗔 𝗔𝗽𝗽𝗿𝗼𝘃𝗲𝘀 𝗞𝗘𝗥𝗘𝗡𝗗𝗜𝗔® (𝗳𝗶𝗻𝗲𝗿𝗲𝗻𝗼𝗻𝗲) 𝘁𝗼 𝗧𝗿𝗲𝗮𝘁 𝗣𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘄𝗶𝘁𝗵 𝗛𝗲𝗮𝗿𝘁 𝗙𝗮𝗶𝗹𝘂𝗿𝗲 𝘄𝗶𝘁𝗵 𝗟𝗲𝗳𝘁 𝗩𝗲𝗻𝘁𝗿𝗶𝗰𝘂𝗹𝗮𝗿 𝗘𝗷𝗲𝗰𝘁𝗶𝗼𝗻 𝗙𝗿𝗮𝗰𝘁𝗶𝗼𝗻 ≥𝟰𝟬%

The mineralocorticoid receptor antagonist (MRA) finerenone (KERENDIA®) was initially used in adults with chronic kidney disease (CKD) associated with type 2 diabetes. The FIDELIO-DKD and FIGARO-DKD Phase 3 trials demonstrated finerenone’s ability to significantly reduce cardiovascular events along with CKD progression as well. Notably, the cardiovascular benefit was driven largely by reduced heart failure hospitalizations, highlighting finerenone’s dual cardio-renal protection.

Building on this evidence, the Phase 3 FINEARTS-HF trial was conducted in patients with heart failure with mildly reduced or preserved ejection fraction. The trial results showed a 16% relative risk reduction in the outcome of cardiovascular death and total HF events.

Based on these results, the U.S. FDA has now approved KERENDIA® to treat patients with heart failure with LVEF ≥40%, a large and growing group of patients with a poor prognosis.

RemediumOne is contributing to further research through the REDEFINE-HF trial, a Phase 3 study evaluating the efficacy and safety of finerenone among hospitalized heart failure patients. Patient recruitment for this trial is currently underway in Sri Lanka, positioning the country as an active participant in advancing heart failure care.

Study sites in Sri Lanka includes:

The National Hospital of Sri Lanka

Colombo North Teaching Hospital

Sri Jayewardenepura General Hospital

Kandy National Hospital

District General Hospital Polonnaruwa

Colombo South Teaching Hospital

Jaffna Teaching Hospital

Negombo District General Hospital

General Sir John Kotelawala Defence University

Dr. Gamini Galappatthy, Consultant Cardiologist at the Institute of Cardiology, National Hospital of Sri Lanka, Colombo is the Coordinating Principal Investigator for the study. With the FDA’s expanded approval for finerenone and the ongoing contribution of South Asian sites through trials like REDEFINE-HF, Sri Lanka is playing a crucial role in the global effort to transform heart failure care, especially in resource-limited settings where heart failure continues to be a major public health challenge.

U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review | Bayer United States