Partners Bristol-Myers Squibb and Pfizer failed to win FDA approval for use of the oral Factor Xa inhibitor Eliquis® (apixaban) in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The agency’s Complete Response Letter (CRL) requested additional information on data management and verification from the Phase III Aristotle trial, but hasn’t asked for the completion of any new studies.
The firms say they will work with the drug regulator to define the next steps toward achieving approval. In the meantime Eliquis is under review in the EU and Japan for the stroke prevention in atrial fibrillation indication, backed by data from 24,000 patients in the pivotal Aristotle and Averroes studies.
Eliquis was approved in Europe in May 2010 for use in the prevention of venous thromboembolic events (VTE) in adults undergoing elective hip or knee replacement surgery. The clinical program for the anticoagulant is projected to include some 60,000 patients across multiple indications, and includes nine completed or ongoing Phase III studies.
BMS and Pfizer teamed up in 2007 to develop Eliquis, which was originally discovered by BMS. Under terms of the initial development plan, Pfizer funds 60% of all development costs, and the firms jointly develop the clinical and marketing strategy, and share commercialization expenses and profits equally on a global basis. BMS manufactures the product.