Pundits Declare Victory in Anticoagulant Contest But It’s Not Over Yet

The pundits and analysts have called it: apixaban (Eliquis), the oral, direct factor Xa inhibitor being jointly developed by BMS and Pfizer, is the winner. Dabigatran (Pradaxa) and rivaroxaban (Xarelto) will fight for the remainder of the market. Yesterday’s announcement of the topline results from ARISTOTLE indicates a clear victory for the drug, say the experts.

But hold on a second. Remember: we’ve only seen a press release from the companies. The only thing they’ve told us is that the trial met its primary endpoint and its secondary endpoint. No actual numbers. No subgroups. No analyses. At this point no one knows the full tale of this trial. And who knows what outside experts or the FDA will find when they get ahold of the details?

Matt Herper in Forbes called the trial a “victory” for BMS and Pfizer and said it “clearly exceeded the expectations of Wall Street analysts and cardiologists.” Well Fargo analyst Larry Biegelsen said the results “appear to be a major win for apixaban  because in the equivalent Xarelto study, Rocket-AF, Xarelto was not superior to warfarin on either efficacy or safety. ” Tracy Staton at Fierce Pharma writes that the ARISTOTLE data “is throwing the contest into disarray… performing far beyond analysts’ expectations.”

To be fair, all the reports I’ve seen mention that the results are only preliminary, and that the complete presentation of the trial won’t occur until the ESC at the end of the August. And I know we can’t expect Wall Street to sit around and wait until then. But for the rest of us there’s no need to rush to judgement. It might be wise to see the full story. We’ve been fooled before.

Comments

  1. I agree! No way it’s over yet. The apixaban data will not be presented until August. Lot’s of clinical questions still to answer.

  2. Marilyn Kaswin says:

    I would like to see the results stratified by age and CHADS2 score before I make an assessment. We will have to wait for the ESC presentation before we pass judgment. Also, by then we will probably have some post-marketing data on dabigatran showing real world clinical data. Also, rivaroxaban is a once daily drug, and we cannot discount this dosing advantage that it will have in terms of ease of use.

Trackbacks

  1. […] It should be noted that the results of ARISTOTLE with another factor Xa inhibitor, apixaban (Eliquis, Pfizer and Bristol Myers), will be presented at the European Society of Cardiology meeting in Paris on August 28. The trial has attracted a great deal of interest, based on a press release that revealed the main results of the trial. […]

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