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.