Friday 5 from Practical Cardiology

Every Friday, Practical Cardiology provides a curated list of 5 articles focused or related to a particular topic. This week, the Friday 5 from Practical Cardiology highlights the 5 most popular articles about FDA news related to cardiovascular care from the first quarter of 2021.

1. Medtronic's Harmony TPV System Receives Historic FDA Approval for Congenital Heart Disease

The FDA announced approval of the Harmony Transcatheter Pulmonary Valve device for treatment of patients with native or surgically-repaired right ventricular outflow tract was awarded to Medtronic Inc.

2. 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.

3. 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.

4. Rosuvastatin/Ezetimibe (Roszet) Combination Therapy Approved for Lowering LDL-C

Althera Pharmaceuticals announced the FDA approved rosuvastatin and ezetimibe (Roszet) as an adjunct to diet for lowering LDL-C in adults patients with primary non-familial hyperlipidemia or homozygous familial hypercholesterolemia.

5. Evinacumab (Evkeeza) Receives FDA Approval as Adjunct Therapy for HoFH

A statement from Regeneron announced their ANGPTL3 inhibitor evinacumab (Evkeeza) received approval as an adjunct therapy for lowering LDL-C in patients 12 years and older with homozygous familial hypercholesterolemia.