FDA approves Merck's Lipfendra, first oral PCSK9 inhibitor for high cholesterol

The U.S. Food and Drug Administration has granted approval to Lipfendra (enlicitide), Merck’s once‑daily oral tablet that blocks the PCSK9 protein. It is the first oral PCSK9 inhibitor, offering an alternative to injectable drugs such as Repatha and Praluent for patients with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia and adults whose LDL cholesterol remains high despite maximally tolerated statins.

Phase‑3 trials showed the pill lowered LDL‑C by 56 % to 60 % after 24 weeks, comparable with the efficacy of injectable PCSK9 inhibitors. The medication is intended as an add‑on to diet, exercise and statin therapy. Merck priced Lipfendra at about $10.50 per day (≈$315 per month) and expects “peak sales potential of tens of billions of dollars.” The FDA used its National Priority Voucher program to expedite review, reflecting the drug’s public‑health relevance.

Dr. Allen Taylor, cardiology chair at MedStar Heart & Vascular Institute, said, “Treating cholesterol more aggressively is our best chance to lower risk for heart disease for millions of Americans.” The approval expands treatment options and could improve adherence for patients who have avoided injectable therapy due to cost, inconvenience, or needle aversion.