FDA approves new kind of cholesterol pill

The Food and Drug Administration on Thursday approved a new cholesterol pill from Merck that works in a different way than statins.

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The daily pill, called Lipfendra, is known as a PCSK9 inhibitor — a class of powerful cholesterol-lowering medications that had previously only been available as injections.

The drug was approved for people with hypercholesterolemia, or high levels of LDL cholesterol, the so-called bad cholesterol.

About one in four adults in the U.S. have high LDL cholesterol, according to the American Heart Association . Too much LDL cholesterol can lead to plaque buildup in the arteries, increasing the risk of heart disease and stroke.

In one late-stage clinical trial , Merck found that Lipfendra lowered LDL cholesterol levels by up to 60% after 24 weeks. In a second trial , people with a genetic condition called heterozygous familial hypercholesterolemia — which causes sky-high cholesterol from birth — saw similar reductions. Nearly all of the people in the trials were already taking a statin, and many were also taking a different cholesterol-lowering drug, ezetimibe.

In March, a group of major medical organizations including the AHA and the American College of Cardiology released new guidelines urging more aggressive treatment of cholesterol . People without heart disease risk factors should aim to get their LDL cholesterol below 100 mg/dL, people at high risk should aim for under 70 mg/dL and for people with heart disease, under 55 mg/dL.

The drug works by blocking the PCSK9 protein, which is instrumental in the production of LDL cholesterol. Statins have a different target: an enzyme that the liver uses to make cholesterol.

The first PCSK9 inhibitor was approved in 2015. The drug, Repatha from Amgen, is an injectable. Regeneron and Sanofi also make an injection PCSK9 inhibitor called Praulent.

Lipfendra will cost $10.50 a day, or $315 for a 30-day supply, according to Merck. The drugmaker expects the out-of-pocket cost will be cheaper.