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Apixaban Shows Mortality Advantage, But Will It Survive FDA Scrutiny?

Executive Summary

Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban) may be the first of the new anticoagulants to show a significant mortality benefit in the atrial fibrillation population, but it remains to be seen whether this advantage will withstand FDA’s regulatory scrutiny.

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Eliquis Approval Delayed By Fraud In China, Dispensing Errors In Pivotal Trial

Despite expectations that Bristol-Myers Squibb/Pfizer’s novel oral anticoagulant apixaban would sail through U.S. 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.

Eliquis Approval Delayed By Fraud, Dispensing Errors In Pivotal Trial

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.

“Marginal” Mortality Benefit Belongs In Eliquis’ Label, But Not The Indication Statement, FDA Says

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.

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