Overview
- Merck won U.S. FDA approval for Lipfendra on Thursday, July 16, 2026, making it the first once‑daily oral PCSK9 inhibitor cleared for adults with high LDL cholesterol including heterozygous familial hypercholesterolemia.
- Two late‑stage CORALreef trials found Lipfendra cut LDL cholesterol about 56% to 59% versus placebo at 24 weeks when added to standard therapy, findings the FDA used to approve the drug.
- The pill works by blocking the PCSK9 protein to preserve liver LDL receptors, must be taken on an empty stomach, and had a safety profile in trials with common side effects of dizziness and diarrhea similar to placebo.
- Merck set a $10.50 per day list price (about $315 per month) and said the drug should reach pharmacies within weeks, but real patient cost and uptake will depend on insurer coverage and prior‑authorization rules.
- A large cardiovascular outcomes trial to test whether Lipfendra lowers heart attacks, strokes and cardiovascular deaths is ongoing with results expected in 2029, and those data will shape long‑term use and payer decisions.