New pill that cuts cholesterol levels gains FDA approval
Jul 16, 2026
A once-a-day pill that lowers blood cholesterol levels below those reached with widely used statins has been approved by the Food and Drug Administration, the pharmaceutical company Merck announced on Thursday.
The drug Lipfendra reduced levels of LDL or low-density lipoproteins, the dangerous ch
olesterol that can lead to plaque build up in your arteries, by up to 60% in clinical trials, according to Merck.
Some participants were able to bring their LDL level to below 50 milligrams per deciliter, according to Merck.
Most adults should keep their LDL level to below 100 but updated guidelines from the American College of Cardiology and the American Heart Association urge people with a higher risk of hearts attack or strokes to reduce theirs to below 70 or lower.
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Lipfendra, which is also called enlicitide, is intended to be paired with a healthy diet and exercise by adults with high levels of cholesterol. It works by inhibiting PCSK9, a protein that impedes your liver’s ability to get rid of LDL cholesterol.
Lipfendra is the first version of a PCSK9 inhibitor available as a pill rather than as an injection. The list price will be $10.50 a day for a 30-day supply.
The approval follows two clinical studies involving a total of 3,207 adults. In one 24-week clinical trial of 2,912 people, Lipfendra lowered LDL levels by up to 60 percent.
Patients who saw a significant a drop in LDL levels including those with inherited hypercholesterolemia and those already taking statins.
Similar numbers of patients taking Lipfendra and those treated with a placebo stopped treatment because adverse reactions.
It is not known if Lipfendra reduces the risk of cardiovascular death.
Statins work by blocking a liver enzyme necessary to produce cholesterol, lowering LDL levels and reducing inflammation in your artery walls, according to Harvard Health Publishing. More than 40 million Americans take them, and they were the most prescribed drugs in the U.S. in 2023.
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