FDA Approves Merck Oral PCSK9 Cholesterol Pill

The U.S. Food and Drug Administration has approved Merck's Lipfendra (enlicitide), the first oral PCSK9 inhibitor for lowering cholesterol, offering a new, convenient pill option for millions of adults with high levels of "bad" LDL cholesterol. The approval was announced on Thursday, July 16, 2026, and the drug is cleared for use alongside diet and exercise in patients with hypercholesterolemia, including those with the inherited condition heterozygous familial hypercholesterolemia (HeFH).

Lipfendra works by blocking the PCSK9 protein, which prevents the liver from removing LDL cholesterol from the bloodstream. This mechanism is distinct from statins, the long-standing standard of care, and allows the new drug to be used in combination with statin therapy for additional cholesterol reduction. The FDA's decision was based on two Phase 3 clinical trials, CORAL-reef Lipids and CORAL-reef HeFH. In those studies, patients taking Lipfendra experienced placebo-adjusted reductions in LDL cholesterol of approximately 56% to 59% after 24 weeks, with some analyses showing reductions approaching 60%.

The approval introduces a significant new competitor to the existing market for PCSK9...