FDA approves Merck's Lipfendra as first oral PCSK9 inhibitor
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Merck’s LIPFENDRA® (enlicitide) is the First and Only Once-Daily Oral PCSK9 Inhibitor Approved by the U.S. FDA to Reduce LDL-C in Adults with Hypercholesterolemia
July 16, 2026 6:45 AM EDTAt week 24 in the CORALreef Lipids and CORALreef HeFH trials, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively
LIPFENDRA is a novel macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved LIPFENDRA® (enlicitide) tablets 20 mg as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults... More
