šØ.š¦. ššš šš½š½šæš¼šš²š ššš„šš”šššĀ® (š³š¶š»š²šæš²š»š¼š»š²) šš¼ š§šæš²š®š š£š®šš¶š²š»šš šš¶ššµ šš²š®šæš šš®š¶š¹ššæš² šš¶ššµ šš²š³š š©š²š»ššæš¶š°šš¹š®šæ šš·š²š°šš¶š¼š» ššæš®š°šš¶š¼š» ā„š°š¬%
The mineralocorticoid receptor antagonist (MRA) finerenone (KERENDIAĀ®) was initially used in adults with chronic kidney disease (CKD) associated with type 2 diabetes. TheĀ FIDELIO-DKD and FIGARO-DKD Phase 3 trialsĀ demonstrated finerenone’s ability to significantly reduce cardiovascular eventsĀ along with CKD progression as well. Notably, theĀ 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 KERENDIAĀ® to treat patients with heart failure with LVEF ā„40%, a large and growing group of patients with a poor prognosis.
RemediumOne is contributing to further researchĀ through theĀ 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 FDAās 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 KERENDIAĀ® (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ā„40% Following Priority Review | Bayer United States
