Federal regulators on Friday approved the first of a new class of drug that can sharply lower cholesterol levels, offering a new option for millions of Americans suffering from cardiovascular disease, the nation’s leading killer.

But the drug, Praluent, which analysts project will become a huge seller, is expected to become the next flashpoint in the growing controversy of escalating pharmaceutical prices, and health plans are expected to put in place strict measures to control which patients can use the drug and prevent it from becoming a budget buster.

The list price of Praluent is about $14,600 a year, substantially higher than the $7,000 to $12,000 that some health plan executives and Wall Street analysts had been expecting. Typically insurers and government health programs get discounts or rebates.

Sanofi and Regeneron Pharmaceuticals, which developed the product, said the price was justified by the potential benefits to patients and savings to the health care system that the drug would provide by preventing heart attacks and strokes — though the ability of the drug to do that has not been proved.