The FDA has approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra), the first member of the class available as a pill in the U.S. The approval targets adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, under the Commissioner’s National Priority Voucher pilot program. Enlicitide is positioned to reduce LDL cholesterol to levels lower than those typically achieved with statins in clinical testing, with Merck reporting side effects comparable to placebo during trial periods. The tablet is intended to be taken once daily alongside diet and exercise. Analysts and market participants expect Lipfendra to compete directly with injectable PCSK9 inhibitors, with the pricing and route-of-administration shift likely to be a key driver of uptake. Merck is also running additional studies to evaluate downstream cardiovascular outcomes for the therapy.