FDA approves a first-of-its-kind pill to cut cholesterol in high-risk patients

The U.S. FDA approved Lipfendra, a first-of-its-kind pill from Merck to cut cholesterol for high-risk patients who need more LDL reduction despite taking statins. The approval announced Thursday allows use in patients whose artery-clogging cholesterol persists even after standard statin therapy. Lipfendra blocks a liver protein called PCSK9, a mechanism previously available largely through expensive injectable drugs from companies such as Amgen, though access has been limited by high prices and insurance restrictions. Merck’s approval was based on two studies in high-risk patients adding the pill to their existing treatment. In one study of 3,000 patients, LDL dropped more than 55% after six months; in another, the average reduction was 59% versus a dummy pill. The benefit persisted with a slight drop over a year, and side effects like dizziness and diarrhea were similar to placebo. The FDA reviewed the drug under an ultra-fast pathway, and the pill must be taken on an empty stomach.