New questions about the efficacy of Abbott's Trilipix drug weren't strong enough to inspire a thumbs down from an FDA advisory panel. The agency's committee of experts recommended in a 9-to-4 vote that Trilipix keep its indication for use with a cholesterol-lowering statin drug. But the panel also called for additional research into the combination's effect on heart risks.
The FDA had asked the panel to weigh data from a study suggesting that adding Trilipix's predecessor, TriCor, to statin therapy didn't provide any better protection against heart attacks and strokes. Committee members determined that the data wasn't airtight because two-thirds of the study patients didn't meet the criteria for high cholesterol on Trilipix's label, Bloomberg reports.
"I didn't feel there was sufficient negative information to remove the indication," panelist David Oakes of the University of Rochester told Reuters. Likewise, panel member Lamont Weide, the chief of endocrinology at the University of Missouri School of Medicine, said, "In my view, we have no data to change anything and we clearly need a study to answer the question."
That's just what the panel is advising FDA to do: Require Abbott to conduct a trial of the Trilipix/statin combination, to determine whether it helps patients with high triglycerides and low HDL, two markers the fibrate drug is designed to improve. About half of the patients who use Trilipix now take it with a statin, while 40 percent is standalone use, Reuters says.