The submission of sNDA is based on the positive results of the Phase 3 clinical trial FINEARTS-HF. The experimental results showed that compared with placebo, Kerendi reduced the composite clinical indicators of cardiovascular death and total heart failure events by 16% based on the patient's existing treatment plan, achieving the primary endpoint of the trial. The results of this study have been published in the New England Journal of Medicine.
In terms of serious adverse events, the difference between the treatment group and the placebo group was small, with a Kerendia group incidence of 38.7% and a placebo group incidence of 40.5%.
Kerendia is a "first in class" non steroidal mineralocorticoid receptor antagonist, which was approved by the US FDA in July 2021 to reduce the risk of continuous estimated glomerular filtration rate (eGFR) decline, end-stage renal disease, cardiovascular death, non fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Heart failure is a complex clinical symptom caused by any structural or functional impairment of ventricular filling or ejection function. In the United States alone, approximately 6.7 million adults suffer from heart failure, of which about 55% have LVEF ≥ 40%. These patients have limited treatment options and are often accompanied by multiple comorbidities such as obesity, hypertension, and chronic kidney disease, which adds extra considerations for doctors in treatment.
The positive data from the FINEARTS-HF study means that the role of Kerendi is not limited to CKD patients with T2D, but can also provide clinical benefits for patients with heart failure (LVEF ≥ 40%).
<Reprinted from WuXi AppTec>
