Bristol-Myers Squibb, Pfizer announce FDA acceptance of Eliquis sNDA for review

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Jul 11 2013

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis^® (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 15, 2014.

The submission is supported by the ADVANCE-1, ADVANCE-2, and ADVANCE-3 clinical trials, part of the EXPANSE clinical trial program. These trials randomized nearly 12,000 patients and assessed the safety and efficacy of Eliquis compared to enoxaparin. ADVANCE-1 and ADVANCE-2 studied patients undergoing elective total knee replacement, and ADVANCE-3 studied patients undergoing elective hip replacement.

SOURCE Bristol-Myers Squibb

Posted in: Medical Condition News | Pharmaceutical News

Tags: Acute Coronary Syndrome, Anticoagulant, Apixaban, Aprotinin, Aspirin, Atrial Fibrillation, Blood Clot, Clinical Trial, Clopidogrel, Consumer Health, Deep Vein Thrombosis, Deep Vein Thrombosis (DVT), Efficacy, Elective Surgery, Embolism, Food, Hemostasis, Heparin, Hip Replacement, Hypersensitivity, Knee, Knee Replacement, New Drug Application, Orthopedic, Pain, Placebo, Pregnancy, Prescription Drug, Prophylaxis, Prosthetic, Protamine, Protein, Pulmonary Embolism, Ritonavir, Stroke, Surgery, Thrombosis, Tranexamic Acid, Venous Thromboembolism, Vitamin K, Warfarin