Advisors to the US Food and Drug Administration have recommended that Abbott Laboratories' lipid lowerer Trilipix should continue to be marketed for use with other cholesterol drugs, but are calling for a label change and further clinical trials to answer questions about safety.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee has reviewed the results of the US government-funded ACCORD study on Trilipix (fenofibric acid) in combination with a statin in patients with mixed dyslipidaemia and at high risk of heart disease. One part of the study compared patients taking the cholesterol-lowerer simvastatin to those taking simvastatin and Abbott's TriCor (fenofibrate), which is similar to Trilipix.
That element of the study found no difference in the cardiovascular outcomes between the two patient groups but six of the 13 panel members have voted that Trilipix' label should be revised to include a discussion of the ACCORD results.
The committee also voted 13 to 0 that the FDA should require a clinical study looking at Trilipix and whether it lowers the risk of heart attacks and strokes. In response, Eugene Sun, Abbott's head of global pharmaceutical clinical development, said the firm "appreciates the committee's recognition that the totality of data, including ACCORD, supports retaining the co-administration indication for Trilipix in appropriate patients".
He added that "we also appreciate the request for more clinical data and look forward to further discussions with the FDA."