The federal Food and Drug Administration has approved a first-of-its-kind pill that sharply reduces artery-clogging cholesterol in people who remain at high risk of heart attacks despite taking statins.
The pill, named enlicitide, will be sold under the name Lipfenrda. Taken daily, it helps rid the body of cholesterol in a way that until now could be done only with injected medicines and significantly more than statins do.
Expected to be available within weeks, it won’t come cheap. According to Merck, the manufacturer, its list price will be $10.50 a day, which. Depending on whether and how much insurers decide to cover it, that could limit the number of people it might reach.
Still, it will offer an easier-to-use option for millions of people.
Statins block some of the liver’s production of cholesterol and are the cornerstone of treatment. Even taking the highest doses, though, many people need additional help to lower their LDL, or “bad,” cholesterol enough to meet medical guidelines.
In a major study, more than 2,900 high-risk patients were randomly assigned to add a daily enlicitide pill or a dummy drug to their standard treatment. The enlicitide users saw their LDL cholesterol drop by as much as 60% over six months, researchers reported earlier this year in the New England Journal of Medicine.
There are other pills that can be taken in addition to the usual treatment, statins, to fight cholesterol. “But none come close to the degree of LDL cholesterol-lowering that we see with enlicitide,” according to Dr. Ann Marie Navar, a cardiologist at UT Southwestern Medical Center who led the study reported in February.
One caveat: The pill must be taken on an empty stomach.
Heart disease is the nation’s leading cause of death, and high LDL cholesterol, which causes plaque to build up in arteries, is a top risk factor for heart attacks and strokes. While an LDL level of 100 is considered fine for healthy people, doctors recommend lowering it at least to 70 once people develop high cholesterol or heart disease — and even lower for those at very high risk.
Statin pills like Lipitor and Crestor, or their cheap generic equivalents, are highly effective at lowering LDL.
For additional help, some powerful injected drugs work differently, blocking a liver protein named PCSK9 that limits the body’s ability to clear cholesterol from blood. But they are even more expensive than Lipfendra. And only a small fraction of people who could benefit from PCSK9 inhibitors use them. While prices for the costly shots have dropped, some people are averse to administering shots.