This article was originally published in Pharmaceutical Approvals Monthly
FDA staff that participated in the review of Bristol-Myers Squibb/Pfizer’s anticoagulant apixaban.
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Despite expectations that Bristol-Myers Squibb/Pfizer’s novel oral anticoagulant apixaban would sail through FDA on the strength of the superior efficacy and safety compared to warfarin in the ARISTOTLE trial, study conduct issues led to a nine-month delay in approval.
Although apixaban demonstrated a significant benefit on all-cause mortality in the ARISTOTLE trial, the statistical fragility of the finding meant the data were relegated to the label’s Clinical Studies section.
A timeline chronicling the development history of Bristol-Myers Squibb/Pfizer’s apixaban.