FDA clears Merck cholesterol pill that cut LDL up to 60%
Why it matters: It is the first once-daily oral PCSK9 inhibitor, offering a non-injection option for adults whose cholesterol remains high.
The FDA has approved Merck’s Lipfendra, making it the first once-daily oral PCSK9 inhibitor for adults with high cholesterol. The drug is cleared as an add-on to diet and other LDL-lowering treatments, including for adults with inherited forms of high cholesterol. In phase 3 trials, Lipfendra lowered LDL, or “bad” cholesterol, by about 56% to 60% when used with statins. Until now, PCSK9 inhibitors such as Repatha and Praluent have been available only as injections. Merck said the pill was generally well tolerated in trials, with diarrhea and dizziness the most common side effects, while serious side effects and treatment discontinuations were similar to placebo.