FDA expects to complete a review of data from the ENHANCE study for Merck and Schering-Plough's Vytorin within nine months, Office of New Drugs Director John Jenkins announced Jan. 25.

Any discussion of a labeling change at this point is "premature," he insisted. "We have not identified any safety issue per se, above and beyond what is already in the labeling." And, he added, "The labeling already makes very clear that there are no data to show that these drugs reduce the risk of cardiovascular disease, such as heart attack or stroke."

The agency will focus its assessment on better understanding the unexpected study results. LDL cholesterol levels declined more in patients receiving Vytorin (ezetimibe/simvastatin) than those taking simvastatin alone, but the endpoint of lower atherosclerotic plaque in the carotid arteries was not obtained.

"Why did the expected decrease in LDL, which was seen, not translate into a decrease in the amount of plaque in the arteries and how [do we] interpret that finding?" Jenkins asked. "We would be interested in looking at how does that compare across subsets of the patients, how does that occur over time."

It is too soon to suggest that LDL-lowering capability is not a suitable basis for drug approval, Jenkins contended. Outcome studies that have been completed for LDL-lowering statins have shown the drugs reduce cardiovascular events, he said.

In the case of Vytorin, a 12,000-patient outcome study, IMPROVE-IT, is expected to be completed in 2011.

While FDA's statements - essentially an endorsement of the current package insert - should be reassuring to the companies, the public furor over the ENHACE trial suggests the agency review could result in two things: a label change and lots of news stories about it when it eventually comes, creating another public relations challenge for the product towards the end of the year.

In the meantime, Congress seems intent on keeping Vytorin, and Rx promotional issues generally, in the headlines (see ¹ Also see "Assault On Drug Marketing Tactics Becomes Drug-Specific On Capitol Hill" - Pink Sheet, 28 January, 2008.).

FDA expects to receive the ENHANCE data within two to three months, and to complete its review within six months thereafter, Jenkins said.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

FDA To Review Vytorin Data: ENHANCEd Label To Follow?

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