The US Food and Drug Administration has approved Lipfendra (enlicitide) from Merck, described across outlets as the first once-daily oral pill in the PCSK9 inhibitor class for lowering LDL (“bad”) cholesterol. The drug is positioned for adults with high LDL cholesterol, including people with inherited forms of hypercholesterolemia, and it is approved as an adjunct to diet and other therapies. Sources say Lipfendra works by blocking PCSK9, a liver protein that normally limits the body’s ability to clear LDL from the blood. Compared with statins, which reduce cholesterol production, Lipfendra uses a different mechanism and can be taken either in addition to statins or as an alternative when statins alone do not achieve target LDL levels or are not tolerated. Several reports note that people previously relied on injectable PCSK9-targeting therapies from other companies; Lipfendra is the first pill option in that treatment category. Clinical trial results reported by outlets include LDL reductions on the order of roughly the high-50% range over about 24 weeks, with side effects varying between studies. The reports also describe Lipfendra’s list price and that actual patient costs may depend on insurance.