FDA Rejects Combo Cholesterol Drug
March 7, 2012 by staff
FDA Rejects Combo Cholesterol Drug, Federal regulators have rejected Merck & Co.’s new combination cholesterol drug, which includes a generic version of the mega-blockbuster Lipitor – at least for now.
It’s unclear how long the ruling, announced Monday, might delay approval of the drug, as the Food and Drug Administration is requiring additional study data on the compound. It combines generic Lipitor, the top-selling drug of all time, with Merck’s cholesterol medicine Zetia.
Approval could boost Merck’s sagging cholesterol franchise by essentially replacing its existing combo pill, Vytorin, with one likely to be seen as more powerful. Vytorin sales have been dwindling for a few years due to concerns about how well it works, and now Merck has to contend with patients possibly defecting to the generic versions of Pfizer Inc.’s Lipitor that came on the market at the end of November.
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.
The experimental drug, still known only as MK-0653C, contains medicines that fight high cholesterol 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, 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.
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