Eliquis Approval Delayed By Fraud, Dispensing Errors In Pivotal Trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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.