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Trilipix to stay on market, but FDA panel recommends new study

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An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks.

An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks.

Trilipix is a fibrate drug approved by FDA in 2008 to lower LDL cholesterol and triglycerides and increase HDL cholesterol. The review and recommendation followed the results of a study released in March 2010 of a similar Abbott drug, TriCor, that showed that diabetic patients taking a fenobibric acid-simvastatin (Zocor) combination had as many heart attacks as those taking simvastatin alone (2.24% vs 2.41% per year, HR 0.92, P=.32).

Based on the review, 9 of 13 panelists voted that the drug's label should keep the combination as an approved use. Six voted that the label should be updated; while 3 said the label did not need to change.

On the requirement to conduct a new study, Wells Fargo Analyst Larry Biegelsen was quoted in a recent Associated Press article, stating that, if required, it could cost Abbott $100 million to conduct and would be a "modest negative,” and that a change in the drug's label would have virtually no effect on the company’s results.

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