FDA approves new kind of cholesterol pill
First oral PCSK9 inhibitor provides an additional treatment option for adults with hypercholesterolemia
The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
PCSK9 inhibitors have previously been available only as injectable therapies. Lipfendra is administered as a once-daily oral tablet and provides an additional treatment option for adults who require further LDL-C reduction despite existing therapies. The approval also reflects continued advances in the development of therapies for chronic cardiovascular disease management.
“Cardiovascular disease remains the leading cause of death in the United States, and elevated LDL cholesterol is one of its most important modifiable risk factors,” said Michael Davis, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research . “This approval provides an additional treatment option for adults with hypercholesterolemia and reflects the FDA’s broader commitment to supporting meaningful advances in patient access and tackling chronic diseases.”
Hypercholesterolemia occurs when there is too much LDL-C in the blood. Over time, excess LDL-C can accumulate within the walls of arteries, contributing to the formation of plaques that narrow blood vessels and restrict blood flow. If a plaque ruptures, it can trigger the formation of a blood clot, increasing the risk of heart attack or stroke. Because high cholesterol typically causes no symptoms, many people are unaware they have the condition until it is detected through routine blood testing. Diet, physical inactivity, excess body weight, and inherited genetic conditions can all contribute to elevated cholesterol levels.
Several classes of medications are available to lower LDL-C, including statins, ezetimibe, and injectable PCSK9 inhibitors. Lipfendra is the first oral therapy to inhibit PCSK9.