FDA Approves Daily Pill to Lower LDL Cholesterol

The Food and Drug Administration approved a once-daily oral drug that reduces LDL cholesterol. The pill, manufactured by Merck and called Lipfendra, is taken with diet and exercise. The drug inhibits the PCSK9 protein that normally prevents the body from clearing LDL from the blood. Prior PCSK9 inhibitors were available only as injections given every two weeks or monthly.

Lipfendra will carry a list price of about $300 a month, compared with roughly $500 for comparable injectables. The American Heart Association estimates that one in four adults has high LDL cholesterol, which can lead to artery deposits and raise the risk of heart attack and stroke.

The FDA based its decision on two late-stage trials showing LDL reductions of 56% to 59% versus placebo. Results were consistent across patient groups, including those with the genetic condition familial hypercholesterolemia.

"Lowering LDL is one of the most effective tools we have in preventive cardiology because it directly targets a major driver of heart disease," said Dr. Jeffrey Berger, director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart.

"The oral format could broaden adoption because many patients and physicians are more comfortable with pills than injections," said Dr. William Soliman, founder and CEO of the Accreditation Council for Medical Affairs. Lipfendra is also intended as an add-on option for patients already taking statins who have not reached target LDL levels.

The drug is expected to reach pharmacies in the coming weeks, though final patient cost will depend on insurance coverage.