FDA issues complete response for Eliquis

Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) said FDA issued a complete response letter for an NDA for Eliquis apixaban to prevent stroke and systemic embolism in patients with atrial fibrillation. According to the partners, the agency requested additional information on data management and verification from the Phase III ARISTOTLE trial, but did not ask for an additional trial. The companies said they are working with FDA to address the agency's requests for the direct factor Xa inhibitor. ...