FDA approves Eliquis

FDA approved Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The direct Factor Xa inhibitor had a March 17, 2013, PDUFA date. Bristol-Myers said the drug will be available in the U.S. by the end of next month with a wholesale acquisition cost of $8.35 per day.

Eliquis' label notes that the drug was superior to warfarin on efficacy (reducing the risk of stroke and systemic embolism) and had significantly lower rates of bleeding vs. warfarin. Last August, the partners reported data from the Phase III ARISTOTLE trial showing that Eliquis was superior to dose-adjusted warfarin on both safety and efficacy. Eliquis' label also includes a boxed warning noting that discontinuing the drug in patients without adequate continuous anticoagulation increases the risk of stroke. ...