BMS/Pfizer’s Eliquis On Priority Review Path Toward March 2012 Approval
This article was originally published in The Pink Sheet Daily
Priority review designation for the Factor Xa inhibitor suggests FDA sees it as a major treatment advance over Pradaxa and Xarelto in reducing the risk of stroke among atrial fibrillation patients.
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The company says a data formatting issue was the reason FDA declined to accept the supplemental application for alemtuzumab for relapsing multiple sclerosis.
The agency’s decision not to approve the Factor Xa inhibitor for treating acute coronary syndrome patients follows a negative recommendation by an FDA advisory committee, which was concerned about missing data in the pivotal ATLAS trial. FDA may be seeking more clarity on the issue of missing vital status follow-up for patients who withdrew consent in that study.
FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.