FDA Approves New Cholesterol-Lowering Drug

By Amy Orciari Herman

Edited by André Sofair, MD, MPH

The FDA has approved bempedoic acid (marketed as Nexletol) to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease for whom statins are deemed insufficient.

The oral ATP citrate lyase inhibitor, the first approved in its class, acts by decreasing cholesterol biosynthesis and upregulating LDL receptors, the manufacturer says. It's indicated as an adjunct to diet and maximally tolerated statin therapy.

In phase 3 studies comprising over 3000 patients, once daily bempedoic acid was superior to placebo (a mean 18% placebo-corrected LDL reduction) in patients also taking moderate- or high-intensity statins.

The manufacturer notes that uric acid levels should be monitored in those taking bempedoic acid, as it may increase risk for gout. Additionally, the drug has been associated with tendon rupture and should not be used in patients with prior tendon disorders.

Bempedoic acid's effects on cardiovascular morbidity or mortality are unknown, the manufacturer says.