Cardiology's Top FDA Approvals in 2021

Cardiology's Top 5 FDA Approvals from 2021

1. FDA Approves Twice-Yearly Inclisiran (Leqvio) for Lowering Cholesterol in ASCVD, HeFH
   Announced on December 22, the approval of inclisiran (Leqvio) comes nearly a year after the original PDUFA date. With approval, inclisiran becomes the first and only siRNA therapy approved to lower LDL-C with twice-yearly dosing.
   
   

1. Finerenone (Kerendia) Gets FDA Nod for Chronic Kidney Disease in Type 2 Diabetes
   With approval on July 9, finerenone became the first nonsteroidal mineralocorticoid receptor antagonist approved by the FDA for treatment of chronic kidney disease associated with type 2 diabetes.
   
   
2. FDA Expands Label for Sacubitril/Valsartan (Entresto) to Include Some HFpEF Patients
   Novartis announced the US FDA has expanded the label for sacubitril/valsartan (Entresto) to include reducing the risk of CV death and hospitalizations for heart failure among patients with chronic heart failure.
   
   
3. FDA Approves Vericiguat (Verquvo) for Treatment of Heart Failure
   The US FDA has approved vericiguat (Verquvo) for reducing the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in patients with HFrEF.
   
   
4. Dapagliflozin (Farxiga) Receives Historic FDA Approval for Chronic Kidney Disease
   The US FDA announced dapagliflozin (Farxiga) received approval for reducing the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression in a statement on April 30.