The drug, called Praluent, must be injected, so it won't be as easy to take as a pill. Because it's in a class of biotech drugs called monoclonal antibodies, it will be pricey — $14,000 a year.
It's in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. It targets PCSK9, a protein that affects the liver's ability to take LDL or "bad" cholesterol out of the blood.
"Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol," the FDA said in a statement.
"Multiple clinical trials have demonstrated that statins lower the risk of having a heart attack or stroke," the FDA added. A trial is going now to see if adding Praluent to statins affects the risk.
"The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given, nasopharyngitis, and flu," FDA said.
It's given as an injection once every two weeks.
The drug is likely to be prescribed to people who cannot tolerate statins, as well. Once a drug is approved, doctors may prescribe it for anything they like.
Richard Arnstine, a 60-year-old orthodontist living in Cleveland, has a bad family history of heart disease and he's one of about 10 percent of people who get a painful, muscle-damaging side-effect from statins.
"I got to the point where at times I literally couldn't open a door because my muscles were so sore," Arnstine told NBC News.
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