FDA rejects Merck’s new combo cholesterol drug

Merck & Co. will have to provide more data on its experimental cholesterol-lowering drug cocktail before the Food and Drug Administration (FDA) will allow it to be sold in the United States. The drug, known only as MK-0653C, is designed to fight high cholesterol in two different ways to reduce the risk of heart attack and stroke.

Merck’s new drug contains a generic version of the statin Lipitor, the top selling drug of all time. Known chemically as atorvastatin, Lipitor works to reduce the amount of cholesterol naturally produced in the liver. MK-0653C also contains Zetia, known as simvastatin, a cholesterol drug made by Merck, which works to reduce the amount of cholesterol absorbed from the food the patient eats.

Merck’s previous foray into cholesterol drugs proved to be a financial bust when studies conducted by the drug company showed Merck’s Vytorin, a combination of Zetia and the statin Zocor, was no better at reducing plaque buildup in neck arteries than Zocor alone, which had been available as an expensive generic for years. Merck tried to cover up the results but eventually caved under pressure from a congressional probe.

Merck says it plans to gather the necessary data on MK-0653C in hopes of gaining FDA approval in the future. The company is eager to win back profits from fledgling Vytorin sales.

Merck also has paid out nearly $6.5 billion since 2007 in lawsuit settlements over claims its Vioxx pain medication caused serious injuries, and from fines and penalties for fraudulent marketing practices for Vioxx and other drugs.

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