Abbott's Trilipix faces loss of combo indication

Another drug faces the loss of an FDA-approved use. This time, it's Trilipix, the Abbott Laboratories heart drug. And just like the proposed revocation of Avastin's indication for breast cancer use, the Trilipix questions are arising in the wake of some unfavorable study data.

An FDA advisory panel will hear evidence for and against use of Trilipix in combination with statins, the cholesterol-lowering medicines. That evidence includes data from the government-funded Accord-Lipid study, which found combining Trilipix's sister drug TriCor with a statin didn't reduce heart attacks or other cardiac problems.

Abbott takes issue with FDA's interpretation of that study and maintains the TriCor-statin combo helped patients with high triglycerides and low HDL, or "good" cholesterol. And that's what the fibrate drugs are designed to do--lower triglycerides and boost HDL. "The labeling for Trilipix is appropriate," Abbott VP James Stolzenbach told Reuters.

The advisory committee will consider several options, including revoking the indication, updating the drug's label with data from the Accord-Lipid study, or maintaining the status quo. The vote will take place Thursday.

Trilipix is approved for use on its own, so losing the combo indication wouldn't be a death sentence. But doctors might reconsider that use of the drug. Trilipix and TriCor together accounted for $1.5 billion of Abbott's 2010 revenues.

- read the Reuters news

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