FDA Approves Pfizer And BMS' sNDA For Eliquis

Pfizer Inc. and Bristol-Myers Squibb Co. announced that the companies have received approval for a Supplemental New Drug Application (sNDA) for Eliquis (apixaban).

The U.S. Food and Drug Administration (FDA) approved Eliquis for the prevention of deep vein thrombosis (DVT) which could lead to pulmonary embolism (PE) following hip or knee replacement surgery in patients.

Brian Daniels, Senior Vice President of global development and medical affairs at Bristol-Myers Squibb, said “Today’s FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.”

Eliquis is an oral selective Factor Xa inhibitor which works to decrease thrombin generation and blood clot formation. The drug is currently indicated for the reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The approval for Eliquis’ sNDA was based on three ADVANCE clinical trials. The trials randomized over 11,000 patients to assess safety and efficacy of Eliquis against enoxaparin.

Steven J. Romano, Senior Vice President and Medicines Development Group Head of Global Innovative Pharmaceuticals Business at Pfizer said “As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians. Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.”

Deep vein thrombosis (DVT) forms in a large vein usually located in the lower leg, thigh, or pelvis and can lead to potentially fatal pulmonary embolism (PE). Patients who undergo hip or knee replacement surgery are usually advised to use anticoagulants for the prevention of DVT and PE.