Merck's Lipfendra Becomes the First Oral PCSK9 Inhibitor to Lower LDL-C

TL;DR Summary
The FDA has approved Lipfendra (enlicitide), Merck’s oral PCSK9 inhibitor, to lower LDL-C in patients not adequately controlled on statins. As the first oral option in this class, enlicitide is a macrocyclic peptide designed to disrupt PCSK9-LDL receptor interactions and is produced via a biocatalytic process using 13 engineered enzymes. Because it’s a pill rather than an injectable antibody, it could be prescribed by general practitioners, expanding access, though cost and adherence remain concerns; patients must fast for 30 minutes after dosing for full absorption.
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