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U.S. FDA Approves ELIQUIS® (apixaban) To Reduce The Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

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.

Efficacy and Safety Profile of ELIQUIS in Patients with Nonvalvular Atrial Fibrillation

The ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) study was designed to compare the effects of ELIQUIS and warfarin on the risk of stroke and systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to ELIQUIS and 9,081 to warfarin) and were followed for a median of 1.7 years. ARISTOTLE was a double-blind, multi-national trial in patients with nonvalvular atrial fibrillation, and one or more of the following additional risk factors for stroke: prior stroke or transient ischemic attack, prior systemic embolism, age ≥75 years, arterial hypertension requiring treatment, diabetes mellitus, heart failure ≥New York Heart Association Class 2, or left ventricular ejection fraction ≤40%. Patients received treatment with ELIQUIS 5 mg orally twice daily (or 2.5 mg twice daily in patients with at least 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL) or warfarin (target INR range 2.0-3.0).

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