The external advisory board to the FDA recommended today (Sept 8th, 2011) to approve Rivaroxaban (Xarelto) for the stroke prevention in atrial fibrillation. More details about the vote can be found here. Today’s recommendation is contrary to the one given by an internal FDA review committee which had recommended 2 days ago to NOT approve the drug for atrial fibrillation (discussed on Clot Connect here).
Now the FDA needs to see how it resolves the discrepancy between their own data review experts’ recommendation of non-approval and this external FDA advisory board’s approval recommendation. A decision is expected by Nov 5, 2011. This process certainly has been and continues to be a rollercoaster ride. For the reader interested in the scientific statistical details that shed light on these discrepant conclusions – focus on “constancy assumption” in noninferiority trials – a detailed discussion is provided in reference 1.
Reference
1. Fleming TR et al. Evaluating rivaroxaban for nonvalvular atrial fibrillation – regularoty considerations. N Engl J Med 2011; prepublished on the web.
ADDENDUM
On Nov 4th, 2011 the FDA approved Rivaroxaban for the atrial fibrillation indication – details here.
Disclosures: I have consulted for OthoMcNeil and Bayer, the companies developing Xarelto.
Last updated: Nov 4th, 2011
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