May 19th, 2011

FDA Panel Delivers Mixed Verdict on Trilipix (Fenofibrate)

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee delivered a mixed verdict on fenofibrate (Trilipix, Abbott). On the one hand, the panel agreed unanimously that the FDA should require Abbott to perform a large clinical trial in high-risk patients with elevated triglyceride levels and low HDL levels who nevertheless have achieved target LDL cholesterol levels on statin therapy.

On the other hand, 9 panelists voted to keep (3 votes) or incorporate the findings from ACCORD (6 votes) in the current label. Four panelists voted to withdraw the indication.

3 Responses to “FDA Panel Delivers Mixed Verdict on Trilipix (Fenofibrate)”

  1. David Powell , MD, FACC says:

    Has the FDA ever mandated such a large trial post approval? Would the company receive any governmental financial support for this important trial? Would the patent be extended? How about the other companies that profit from the sale of fibrates?

  2. So let me get this straight… we have a drug approved…a $1.5b+ drug… and no evidence that it improves patient outcomes… and the verdict might be to keep on with business as usual … the call for a trial is not much of a remedy to the current situation – under the best of circumstances will not yield any new information for a decade. Shouldn’t a drug need to show that it helps people – two trials of fenofibrate have so far failed to do that.

  3. David Powell , MD, FACC says:

    So..Helsinki and VA-HIT…both superceded by the mounting statin benefits and mandates derived in the subsequent years. A niche for statin ntolerant patients? FIELD..a negative trial..but possibly confounded by discretionary statin use. ACCORD..negative trial..but for some reason not prospectively powered for the subgroup seemingly more likely to benefit.
    Harlan’s provocative point is well taken..from a societal view, older or ” me too” older drugs should be re-evaluated. But where to draw the line? How about niacin..? In the current statin era, similar to fibrates. With one exception: large trials ..notwithstanding their utility and quality…have not been completed. Taking a drug off market in the absence of reproducible real harm is and should be more difficult..the absence of benefit should be more exhaustive compared with new drugs.
    So it comes down to comparative effectiveness trials and their design. What was the role and expectations of the FDA in ACCORD design?
    For now..I believe the best policy would be to restrict use to statin intolerant patients with trig above say 200 and for statin tolerant patients…250.Cutoffs are fairly arbitrary and the process perhaps too cumbersome. The above proposed trial would remain mandatory.

    Competing interests pertaining specifically to this post, comment, or both: