The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, to lower LDL cholesterol in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).

The drug's approval comes after two randomized, double-blind, placebo-controlled trials including 3,207 patients with hypercholesterolemia on maximally tolerated statin therapy saw an average 56% and 59% reduction in LDL cholesterol, respectively. The second trial enrolled patients with HeFH.

Access the FDA press release for more information.

Clinical Topics: Dyslipidemia, Homozygous Familial Hypercholesterolemia, Lipid Metabolism, Nonstatins

Keywords: United States Food and Drug Administration, PCSK9 protein, human, Cholesterol, LDL, Hypercholesterolemia, ACC Advocacy