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BMS/Pfizer’s Eliquis On Priority Review Path Toward March 2012 Approval

 
• By Sue Sutter

Priority review designation for the Factor Xa inhibitor suggests FDA sees it as a major treatment advance over Pradaxa and Xarelto in reducing the risk of stroke among atrial fibrillation patients.

FDA’s priority review designation for Bristol-Myers Squibb Co./Pfizer Inc.’s Eliquis (apixaban) suggests the agency believes it offers a major treatment advance over two other recently approved anticoagulants – Pradaxa and Xarelto – in reducing the risk of stroke among atrial fibrillation patients.

BMS and Pfizer announced Nov. 29 that FDA has granted a six-month review for the Factor Xa inhibitor, setting a PDUFA goal date of March 28, 2012

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