New Cholesterol Medicine.

Praluent is the first in a new class of cholesterol-lowering biotech drugs to come before the FDA. The drugs are considered the first major advance in lowering bad, or LDL, cholesterol since the introduction of blockbuster statin drugs in the late 1980s.

More than 73 million U.S. adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Patients with high cholesterol have double the risk of heart disease.

Across company studies, patients taking Praluent, in addition to a statin, saw their cholesterol fall 46 to 60 percent, depending on the dose taken. That was significantly more than the reduction of 20 to 22 percent for patients taking a statin alone.

FDA regulators are weighing whether to approve Praluent based on its cholesterol-lowering benefit, or whether to wait for longer-term studies designed to show whether it actually reduces heart attacks and death in patients. Those data are not expected until 2017.

In 2006 Pfizer halted a study of its cholesterol drug torcetrapib, after study results actually showed higher rates of heart problems and death in patients taking it.

But the prospect of approving a new class of expensive injectable drugs for such a common condition has raised concerns among providers and payers, who worry about rising drug costs. Particularly since most statin drugs, including Zocor and Lipitor, are now available as cheap generics.

A new class pops up as the old one goes Generics. The role of Food intake can't be ignored.   Just a thought.