FDA approves new kind of cholesterol pill
The FDA has approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor designed to lower LDL cholesterol in adults with hypercholesterolemia. This new medication offers an alternative to existing injectable PCSK9 therapies for patients who require additional cholesterol reduction.
Why it matters
As the first oral version of a potent class of cholesterol-lowering drugs, this approval significantly improves patient accessibility and convenience for managing chronic cardiovascular disease.
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.
Get smarter about the news
Sign up free for a feed built around what you actually care about, Dive Deeper research on any story, and the full text of every article.
Create free accountAlready have an account? Sign in