Eliquis Approval Delayed By Fraud, Dispensing Errors In Pivotal Trial
This article was originally published in Pharmaceutical Approvals Monthly
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.
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Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.
Although coagulation level monitoring would negate the newer drugs’ convenience advantage over warfarin, FDA reviews of Daiichi’s Savaysa suggest a tailored dosing approach is needed to optimize antithrombotic benefits against bleeding risks.
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.