FDA OKs first non-statin pill to treat high cholesterol in almost two decades
WASHINGTON — The FDA on Friday approved the first non-statin oral medication for high cholesterol in almost two decades, giving patients and doctors another weapon against heart disease, the No. 1 killer in the United States and around the world.
The drug, bempedoic acid, is the first in a new class of drugs to treat lowdensity-lipoprotein cholesterol, also called “bad” cholesterol, which causes the buildup of fatty deposits in the arteries, reducing blood and oxygen flow.
Cardiologists said the new drug, which is taken as a pill once a day, will be used primarily as an addon therapy for people who are taking as high a dose of statin medications as they can tolerate but still have higher-than-desired cholesterol. Studies showed that bempedoic acid reduced cholesterol by an average of 18% in patients taking moderate- or highdose statins, compared to the placebo group, said the manufacturer, Esperion Therapeutics Inc.
The medicine also can be used for patients who can tolerate only low-dose statins or can’t take statins at all. In studies involving those patients, it reduced LDL cholesterol by 28%, the company said.
Esperion, which is based in Ann Arbor, Mich., said the drug’s brand name will be Nexletol. Esperion also has applied to the FDA for approval of a combination pill of bempedoic acid and ezetimibe, a non-statin pill approved in 2002. In studies, the combination pill reduced cholesterol by about 38% to 44%, depending on whether a person was taking a statin and how much, the company said.
The FDA decision is expected shortly.
Statins, which were introduced in the 1980s, are the premier medicines for high cholesterol and typically are the first drugs prescribed along with changes in diet and exercise.
The FDA approved bempedoic acid based on its cholesterol-lowering effect. Whether the drug reduces the risk of heart attacks and strokes is being studied as part of a large outcomes trial involving people who can’t tolerate the side effects of statins.