In a blow for Merck & Co.'s ($MRK) cholesterol franchise, an FDA advisory panel shot down its bid to tout Vytorin and Zetia as preventives against heart attacks and strokes.
The U.S.-based drugmaker had asked the agency to approve a label update stating that the drugs reduce the risk of "cardiovascular events," including heart attack, stroke, cardiovascular death and several others, in patients with coronary heart disease. Merck based its application on data from the 18,000-patient Improve-It study, published earlier this year.
That outcomes trial showed that Vytorin--a combination of the off-patent statin drug simvastatin with the active ingredient in Zetia, ezetimibe--beat simvastatin alone at cutting CV risks, measured by a "composite endpoint" that included heart attacks and strokes along with several other heart complications. Vytorin reduced those risks by 6.4%, the trial found.
But ahead of the panel meeting, FDA reviewers had noted that the reduction in risk was small, and that it was limited to certain types of patients, particularly the elderly and diabetics.Dr. Milton Packer
The FDA advisory committee agreed, voting 10-to-5 against the label update. "The benefit here is small," said panelist Dr. Milton Packer of Baylor University Medical Center (as quoted by Reuters). "It is not robust. You blink and you miss it, and you wonder if you care or don't care."
The FDA reviewers had calculated that 50 people would need to take Zetia along with a statin for seven years to prevent just one of the CV events that made up the trial's primary endpoint. Merck has also asked the FDA to grant Zetia a new indication as an add-on to other statins besides simvastatin, sold under the brand name Zocor.
Nevertheless, many had expected Merck to win the committee's backing for the update. Though the benefits were small, they were statistically significant. Some of the panel members agreed; Reuters noted that Dr. William Hiatt, a professor at the University of Colorado School of Medicine, said the FDA's role is to determine whether the trial delivered statistically significant results. Whether that's a meaningful clinical benefit should be left for others to decide, including payers, he said.
The FDA typically follows its advisory panels' advice, but it doesn't always. Merck is counting on that fact. "Today's discussion is one step in the regulatory process," VP of cardiovascular diseases Dr. Daniel Bloomfield said in a statement. "We believe that Improve-It showed that ezetimibe in combination with a statin offers a significant benefit to high-risk patients with coronary heart disease and are committed to continuing to work with the FDA so that they can complete the review of our request for new indications for Vytorin and Zetia."
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