FDA Speaks on Merck & Schering's Vytorin


I listened in on the hour-long Food and Drug Administration conference call with reporters regarding Vytorin, and I wanted to pass along a few highlights.

The agency said it expects to receive the full set of data from Merck and Schering-Plough on the ENHANCE study within the next two to three months.

ENHANCE is the acronym** for the study that compared Merck and Schering's cholesterol fighter Vytorin (a combo of Zocor and Zetia) to Zocor -- which is now available as a generic -- alone.

Then, officials estimate it will take FDA staff as long as another six months to review the "thousands of pages of documents." This is the study that shows Vytorin lowers cholesterol more than Zocor alone, but didn't cause a significant reduction in the thickness of the dangerous plaque in arteries in the neck.

Dr. John Jenkins, the FDA's Director of the Office of New Drugs said, "It's an unexpected finding. We would have expected lower (bad cholesterol) would have translated into less plaque thickness."

After combing through the data, the agency says it may be able to decide what, if any, action to take.

That could include a label change for Vytorin and/or a change in the criteria for approval of cholesterol-lowering drugs in the future. But, they added, "It's premature to speculate on regulatory action."

In the meantime, FDA officials says doctors and patients should decide on a case by case basis which drug they think is best.


While Merck and Schering-Plough have to be very concerned with the drop in Vytorin and Zetia prescriptions (Vytorin is a combo of Zocor and Zetia) in the wake of the study and the precipitous drops in their stock prices, FDA officials say they're concerned about public health.

On the call, they indicated they're worried that many patients may read and hear recent media coverage of the Vytorin study and stop taking their cholesterol-lowering drugs. "We're very distressed," said Dr. Robert Temple, the FDA's Director of the Office of Medical Policy.

Dr. Jenkins added, "We have to be very cautious and not overreact to this one study. That could have significant public health consequences that could drive people away from reducing their risk (of heart trouble) by lowering their cholesterol."

The FDA officials said they told Merck and Schering-Plough yesterday that they were going to hold this call today, which, they added is standard operating procedure. However, I think that might explain why the companies put out a joint press release this morning saying "they strongly object to mischaracterizations" being made about the ENHANCE study findings.

The next chapter, barring any unexpected developments, should be when Merck reports earnings next Wednesday morning.

**(ENHANCE = Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia.)

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