The FDA has approved enlicitide (LIPFENDRA) as the first oral PCSK9 inhibitor for adults with hypercholesterolemia.
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Enlicitide is indicated as an adjunct to diet and exercise for reducing low-density lipoprotein cholesterol.
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The approval was based on results from the phase 3 CORALreef Lipids and CORALreef HeFH trials.
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In these trials, enlicitide demonstrated significant reductions in LDL-C and other lipid parameters compared to placebo.
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Adverse reactions were similar between enlicitide and placebo groups, with diarrhea and dizziness reported more frequently in enlicitide-treated patients.
