The U.S. Food and Drugs Administration (FDA) have rejected Merck & Co.'s new combination cholesterol drug, at least for now.
The length of delay in approval is not clear yet as the FDA has called for additional study data on the compound. It combines generic Lipitor (Atorvastatin), the top-selling drug of all time, with Merck's cholesterol medicine Zetia (Ezetimibe).
The experimental drug, still known only as MK-0653C, contains medicines that fight high cholesterol in two different ways to reduce risk of heart attack and stroke. Lipitor, known chemically as atorvastatin, is part of the widely used class of drugs called statins that reduce the amount of cholesterol naturally produced in the liver. Zetia or Ezetimibe, on the other hand, reduces the amount of cholesterol absorbed from the food the patient eats. Vytorin includes Zetia and an older statin, Merck's Zocor, also called simvastatin.
Sales of Vytorin and Zetia both were hurt when Merck in early 2008 finally released unfavorable results from a study. The study showed that Vytorin was no better at reducing plaque build-up in neck arteries than just Zocor, which had been available as a cheap generic since 2006. Zetia is protected by patent in the U.S. until 2017.
The Food and Drug Administration issued a so-called Complete Response Letter for the pill, asking Merck to submit more data. It was unclear what data would be required. Merck said Monday that company officials will talk with the FDA to determine the next steps, adding that some new data expected later this year may address the FDA's concerns.
Merck spokeswoman Pamela Eisele said that the FDA did not ask for any information about the ongoing study, called IMPROVE-IT, to test whether Vytorin lowers heart attack risk compared to Zocor. Instead, Merck’s statement appears to be referring to two ongoing studies of Lipitor and Zetia taken as single pills and the new combination pill Merck is testing.