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

June 3, 2011

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.