FDA approves Merck's Lipfendra cholesterol pill

The U.S. United States — Food and Drug Administration (FDA) approved Lipfendra (enlicitide), a once-daily oral PCSK9 inhibitor developed by Merck & Co., for adults with high cholesterol, including heterozygous familial hypercholesterolemia. It is the first oral drug in the PCSK9 inhibitor class, previously only available as injectables from Amgen, Regeneron, and Sanofi. Clinical trials showed LDL cholesterol reductions of up to 60% when added to statin therapy. Merck priced Lipfendra at $315 for a 30-day supply, lower than injectable alternatives. The approval was based on phase 3 CORALreef trials published in The New England Journal of Medicine and JAMA. An ongoing trial is assessing cardiovascular outcomes. The FDA used its accelerated review pathway created by former chief Marty Makary, who resigned in May 2026. The American Heart Association and American College of Cardiology have issued updated LDL targets. The drug is expected to improve patient adherence by offering a needle-free option.