The FDA has approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, expanding the PCSK9 class beyond injections. The approval follows a National Priority Voucher framework and provides a convenient daily tablet option aimed at lowering LDL-C to levels substantially below statin-only therapy in clinical studies.