LEVERKUSEN (dpa-AFX) - Bayer AG (BAYZF.PK) Monday said its Phase III FINEARTS-HF study evaluating Kerendia in patients with heart failure having a LVEF (left ventricular ejection fraction) greater than or equal to 40 percent, met primary goal. LVEF is a measurement that indicates how much blood the left ventricle of the heart pumps with each beat.
The study achieved the primary endpoint of statistically significant reduction of the composite of cardiovascular death and total heart failure events.
Kerendia is already approved to reduce the risk of cardiovascular death, non-fatal heart attacks, hospitalization for heart failure, kidney function decline, and kidney failure in adults with chronic kidney disease associated with type 2 diabetes.
Bayer will present the data at the European Society of Cardiology Congress 2024 in September. The company also and plans to discuss submission for regulatory approval with the FDA.
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