FDA Issues Complete Response Letter to NDA for Eliquis
Bristol-Myers Squibb and Pfizer announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The CRL requests additional information on data management and verification from the ARISTOTLE trial. Bristol-Myers Squibb and Pfizer will work closely with the FDA on the appropriate next steps for the ELIQUIS application. The FDA has not requested that the companies complete any new studies. FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.
Eliquis is an oral direct Factor Xa inhibitor.