FDA approves first oral PCSK9 inhibitor to slash LDL cholesterol

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, to be used with diet and existing LDL-lowering therapies in adults with high cholesterol, including inherited forms. In phase 3 trials, Lipfendra reduced LDL cholesterol by about 56%–60% when added to statin therapy, roughly doubling the impact of many statin regimens. The pill offers a convenient alternative to injectable PCSK9 inhibitors and was generally well tolerated, with diarrhea and dizziness as common side effects and similar discontinuation rates to placebo. Merck noted that large cardiovascular-outcome data are still pending, with results expected in 2029.