Eliquis Approval Delayed By Fraud In China, Dispensing Errors In Pivotal Trial
This article was originally published in PharmAsia News
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.
You may also be interested in...
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.
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.