Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS® (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Atrial fibrillation, the most common type of irregular heartbeat, affects approximately 5.8 million people in the U.S., and results in a five times greater risk of stroke. In the U.S., 15 percent of strokes are attributable to atrial fibrillation.
"The approval of ELIQUIS offers patients with nonvalvular atrial fibrillation a novel treatment option for reducing the risk of stroke," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "ELIQUIS is the result of leading scientific innovation and the shared vision of our alliance to introduce a new oral anticoagulant for patients with nonvalvular atrial fibrillation in the U.S."
Ian Read, chairman and chief executive officer, Pfizer Inc. said, "The profile of ELIQUIS, combined with the strong legacy and complementary capabilities that Pfizer and Bristol-Myers Squibb have in the cardiovascular space, positions us well to deliver this important new treatment option to patients and health care professionals."
The ELIQUIS clinical trial program is the largest completed clinical development program designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients; it included two landmark Phase 3 studies -- ARISTOTLE and AVERROES -- in patients with nonvalvular atrial fibrillation and at least one additional risk factor for stroke. ARISTOTLE evaluated ELIQUIS versus warfarin in 18,201 patients with nonvalvular atrial fibrillation who were suitable for warfarin therapy, and AVERROES evaluated ELIQUIS versus aspirin in 5,598 patients with nonvalvular atrial fibrillation who were considered unsuitable for treatment with warfarin.
The Full Prescribing Information for ELIQUIS includes a Boxed Warning for patients who discontinue treatment. Patients on ELIQUIS who discontinue treatment are at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered.
ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding. Please see additional Important Safety Information included in this release.
"With a population that is living longer, the prevalence of nonvalvular atrial fibrillation is increasing, but many patients are still not being managed effectively with warfarin," said Christopher Granger, M.D., Professor of Medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C., ARISTOTLE lead investigator. "ELIQUIS represents a significant advance over warfarin for health care professionals to reduce the risk of stroke in patients with nonvalvular atrial fibrillation."
ELIQUIS is an oral Factor Xa inhibitor anticoagulant. By inhibiting Factor Xa, a key blood clotting protein, ELIQUIS decreases thrombin generation and blood clot formation. ELIQUIS does not require routine monitoring using International Normalized Ratio (INR) or other tests of coagulation and there are no known dietary restrictions. ELIQUIS can be taken with or without food.
ELIQUIS is expected to be widely available in the U.S. by the end of January 2013.
Bristol-Myers Squibb Company