Millions of Americans suffering from cardiovascular disease now have a new option to better their plight in the form of a new class of a drug that won the approval from federal regulators on Friday. Cardiovascular disease is the nation’s number one killer.

However, analysts fear that the drug could give further rise to the controversy over significant hike in prices of drugs. A patient requires to shell out about $14,600 a year for Praluent, which analysts predict to become a huge seller. However, the annual price for the treatment is much higher than what was expected by health plan executives and Wall Street analysts.

Sanofi and Regeneron Pharmaceuticals, the product developer, say that those who think that the price of the drug is very high need to understand that benefits of the drug for patients and savings to the health care system are justifiable enough for its price.

“Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol”, said the FDA in a statement.

Elias Zerhouni, head of research and development at Sanofi, said price of the drug reflects value, not what the market will bear.

Clinical trials’ results have showed that Praluent significantly reduces levels of LDL cholesterol by 40% or more. The drug will be injected in patients and is the first of its kind to get a green signal from the FDA for sale in the US market.