Merck’s oral PCSK9 inhibitor enlicitide (LifpFendra) won U.S. FDA approval, giving the first once-daily pill option aimed at adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. The approval arrives via the FDA’s National Priority Voucher program. The agency cleared enlicitide tablets for use alongside diet and exercise. Merck is now positioned to compete directly with injectable PCSK9 therapies on convenience and price. Analysts cited in the reporting estimated peak sales near $5 billion. Clinically, the key point is the magnitude of LDL-C reduction observed in trials, with the drug lowering levels below targets typically achievable on statins alone. Merck is also studying whether the therapy can reduce heart attack and stroke risk.