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

 
• By Sue Sutter

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.

Pivotal trial data suggesting a survival advantage with Bristol-Myers Squibb Co./Pfizer Inc.’s Eliquis (apixaban) over warfarin in the atrial fibrillation population was thought to set the Factor Xa inhibitor apart from the two other novel oral anticoagulants recently approved by FDA. In the end, however, the mortality data and its presentation were not all that different from Boehringer Ingelheim GMBH’s direct thrombin inhibitor Pradaxa (dabigatran).

While the apixaban mortality findings in ARISTOTLE were statistically significant, they just barely met this threshold. In review documents, agency staff used such words as “marginal” and “fragile” to describe the benefit

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