FDA Approval of Finerenone (Kerendia) for Expanded Heart Failure Indications – July 14. 2025
FDA Approval of Finerenone (Kerendia) for Expanded Heart Failure Indications – July 14. 2025
1. Drug & Manufacturer:
• Finerenone (Kerendia)
• Developed by Bayer
• A non-steroidal mineralocorticoid receptor antagonist (MRA)
2. New FDA Approval:
• Approved to treat heart failure patients with LVEF ≥ 40%
• Includes:
• HFmrEF (Heart Failure with mildly reduced Ejection Fraction)
• HFpEF (Heart Failure with preserved Ejection Fraction)
• Previously approved for patients with CKD + Type 2 Diabetes
3. Expanded Eligibility:
• Now approved for HF patients without CKD or T2D
• Significantly broadens the eligible treatment population
4. Supporting Evidence:
• Based on results from FINEARTS-HF, a Phase III, Bayer-sponsored trial
• Demonstrated improved outcomes in HFmrEF and HFpEF populations
• Reduced hospitalization and cardiovascular death rates
5. Unmet Need Addressed:
• Despite current therapies:
• 21% of symptomatic HF patients progress to hospitalization or CV death
• 25% of hospitalized patients are readmitted within one year