FDA clears first oral PCSK9 inhibitor for LDL-C reduction

The FDA approved Merck’s enlicitide (branded Lipfendra), the first oral PCSK9 inhibitor for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, under the Commissioner’s National Priority Voucher pilot program. The once-daily peptide is intended to lower LDL-C beyond diet and exercise and positions Merck against injectable PCSK9 antibodies.