FDA approval: first oral PCSK9 option for LDL reduction

The FDA approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) to lower LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. The approval positions the once-daily pill as the first oral PCSK9 therapy in the U.S. and arrives under the National Priority Voucher framework.