The FDA has approved Merck’s Lipfendra (enlicitide) based on phase 3 trials that demonstrated that the oral drug significantly reduces low-density lipoprotein cholesterol (LDL-C).
Lipfendra is a novel macrocyclic peptide that inhibits PCSK9 with LDL receptors by binding to PCSK9. It is the first PCSK9 inhibitor to receive FDA approval to treat hypercholesterolemia.
At week 24, Lipfendra reduced LDL-C by a placebo-adjusted 56% in the CORALreef Lipids trial on patients with hypercholesterolemia and by 59% in the CORALreef HeFH trial on patients with heterozygous familial hypercholesterolemia (HeFH). Participants received 20 mg of lipfrendra once daily in conjunction with improvements to diet and exercise.
Merck is currently running a clinical trial to determine the efficacy of lipfendra in reducing cardiovascular morbidity and mortality.