An FDA panel is scheduled to vote on the use of Abbott's drug TriLipix (fenofibric acid) in combination with a statin after a study involving the company's similar drug TriCor (fenofibrate) raised questions over its effectiveness.


The panel, which will meet on May 19, will be asked to discuss findings of the ACCORD trial, which investigated TriCor in combination with simvastatin in approximately 5500 patients with type 2 diabetes who were at high risk of developing heart disease. Results released last year showed that there was no significant reduction in the number of heart attacks, strokes and cardiovascular deaths in people taking TriCor and simvastatin, compared with those taking simvastatin alone.


In documents released ahead of the meeting, the FDA noted that "since complete data were not available, it is difficult to definitively assess the safety profile of fenofibrate plus simvastatin versus simvastatin plus placebo."


 The agency also said that fibrates, such as TriCor, have been studied in at least five large trials that "have produced mixed results." The panel will be asked to vote on various options for TriLipix, including allowing the product to continue to be marketed without changes to the label or making changes to the label that would incorporate the findings of the ACCORD study. The panel will also be asked whether the drug's approval in this indication should be withdrawn.


Jim Stolzenbach, head of cardiovascular development for Abbott, said that the study's findings aren't surprising given the fact that two-thirds of the trial's participants wouldn’t have received TriCor under current treatment guidelines. He added that if the appropriate patients are treated with the drug, "they are going to get benefit."


Wells Fargo analyst Larry Biegelsen suggested that the impact to Abbott from the FDA's final decision has been minimised because TriCor is already expected to lose revenue when

 generic versions reach the market in mid-2012. He estimated that sales of the drug will fall to $990 million next year and decline further in later years. Combined revenue from TriLipix and TriCor reached nearly $1.6 billion last year.
 

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