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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
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At 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., July 16, 2026 - 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. LIPFENDRA is indicated as an adjunct to
diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with
hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.
LIPFENDRA is a novel macrocyclic peptide and is the first FDA-approved oral PCSK9 inhibitor shown to lower LDL-C, also known as bad cholesterol.
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