The U.S. Food and Drug Administration (FDA) has recently approved several new drugs and medical devices as well as expanded indication for life-saving treatments:

• The FDA has approved Verquvo (vericiguat) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient intravenous diuretics in adults with symptomatic chronic HF and ejection fraction less than 45%. The approval is based on results from the VICTORIA trial presented at ACC.20/WCC. Learn more on the FDA website.
• The FDA has also approved DiamondTemp, a temperature-controlled, irrigated radiofrequency ablation system with diamonds for the treatment of paroxysmal atrial fibrillation that is unresponsive to drug therapy. The approval was made based on results from the DIAMOND-AF trial. Read an overview, including when it should not be used, on the FDA website.
• Evkeeza (evinacumab-dgnb) has also been approved by the FDA as an adjunct to other LDL-C lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). The approval is based on findings from the ELIPSE HoFH trial. Read the full FDA announcement.
• The FDA has granted an expanded indication for Entresto (sacubitril/valsartan) to lower risk for cardiovascular death and HF hospitalization in adult patients with chronic HF, based on results from the PARAGON-HF trial. According to Novartis, "benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal," and "the label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat."

Stay tuned to other FDA updates in 2021 in the ACC Advocate newsletter, on social media (@Cardiology) and ACC.org/Advocacy.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Advocacy, United States Food and Drug Administration, Heart Failure

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