July 16, 2026
Alison Young/USA Today via Reuters Connect
The FDA has approved a new, daily pill that lowers LDL cholesterol levels as effectively as similar, injectable drugs.
The Food and Drug Administration has approved a new daily pill shown to reduce cholesterol levels significantly more than statin medications that have long been on the market.
The drug, made by the pharmaceutical giant Merck, is called enlicitide, and sold under the brand name Lipfendra. The drug lowers low-density lipoprotein cholesterol (LDL), known as bad cholesterol, by inhibiting the production of PCSK9 proteins. These proteins cause plaque build-up in the arteries, putting people at higher risk for heart disease and stroke.
Other powerful PCSK9 inhibitors are already available, but they are injection medicines and cost $500 to $600 a month, compared to the $315 price tag for a month's supply of Lipfendra pills. PCSK9 inhibitors can reduce the risk of heart attacks in high-risk patients by as much as 20%, the New York Times reported.
Merck has plans to offer Lipfendra through TrumpRx.gov, which gives discounts on certain prescription medications. Some health insurance plans also may lower the monthly cost of Lipfendra, the Wall Street Journal reported.
"This would make a big difference compared with the cost of injectable PCSK9 inhibitors," Dr. David Maron, a Stanford University cardiologist, told the New York Times. Lipfendra is expected to become available in the coming weeks.
About 47 million people in the United States are on medication to control cholesterol levels. Most of them take statins, which lower LDL cholesterol by interfering when the liver makes cholesterol. The PCSK9 injectables have been used in high-risk patients when statins and lifestyle changes in diet and exercise have not sufficiently lowered LDL levels, according to Harvard Health.
Lipfendra was shown in clinical trials to reduce LDL levels by about 55% to 60% in six months. That can bring LDL levels beneath 50 or 60, much lower than statins typically reduce LDL.
The American Heart Association and American College of Cardiology recently revised guidelines, saying that high-risk patients with elevated cholesterol and diabetes should get their LDL levels below 70. Sometimes, even a high-dose statin is not enough, and patients need to supplement treatment with a PCSK9 inhibitor.
"The ability to meaningfully reduce LDL well above what you achieve on statins alone, in an easy-to-take pill, we think can really change care in the U.S. and go after one of the biggest killers," Merck Chief Executive Robert Davis told the Wall Street Journal.
