The FDA approved Merck’s Lipfendra (enlicitide), the first oral PCSK9 inhibitor, for lowering LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. The Commissioner’s National Priority Voucher pilot program supported the review. Clinicians now get an oral alternative to injectable PCSK9 therapies, potentially reshaping adherence and treatment sequencing for high-risk patients who require additional LDL lowering despite diet and existing options.