FDA approves Lipfendra, first oral PCSK9 inhibitor for cholesterol

The U.S. Food and Drug Administration has approved Lipfendra (generic name enlicitide), the first oral inhibitor of the PCSK9 protein, for adults with hypercholesterolemia, including those with heterozygous familial high cholesterol. The once‑daily tablet is intended as an adjunct to diet, exercise and statin therapy.

Clinical trials involving more than 3,200 participants showed average LDL‑cholesterol reductions of 56 % to 59 % after 24‑28 weeks, with reductions up to 60 % over about six months. Safety findings were comparable to placebo, with the most common adverse events being dizziness and diarrhea. Michael Davis, interim director of the FDA’s Center for Drug Evaluation and Research, said, “Cardiovascular diseases remain the leading cause of death in the United States, and elevated LDL cholesterol is one of the most important modifiable risk factors.”

Merck Sharp & Dohme LLC will market the drug under the brand name Lipfendra, priced at roughly $315 for a 30‑day supply. The approval offers a non‑injectable alternative to existing PCSK9‑targeting biologics, expanding treatment options for patients who cannot achieve LDL targets with statins alone.