FDA: Cholesterol Drug

March 7, 2012 by staff 

FDA: Cholesterol Drug, The FDA has requested more data from Merck on the company’s investigational cholesterol-lowering drug that combines ezetimibe (Zetia) and generic atorvastatin (Lipitor).

In a complete response letter, the FDA said it has completed its review of the company’s new drug application but will need additional information before moving forward, according to a statement from Merck.

There was no indication from the agency as to whether the request would delay approval of the drug. Merck said new data about the drug — known as MK-0653C — will be available later this year.

Merck’s combination of ezetimibe and simvastatin (Zocor), known as Vytorin, has been available for more than a decade. However, enthusiasm for the drug has waned in recent years, particularly in the wake of the disappointing ENHANCE trial results.

In ENHANCE, the use of Vytorin in patients with heterozygous familial hypercholesterolemia did not slow down the progression of atherosclerosis, which was measured via carotid intima-media thickness.

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