Pfizer Global Innovative Pharmaceuticals Business Medicines Development Group head and senior vice president Dr Steven J Romano noted as the number of hip and knee replacement surgeries performed in the US 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," Dr Romano added.
The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue Eliquis without adequate continuous anticoagulation; and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture.
This sNDA approval for Eliquis is supported by three clinical trials (the ADVANCE clinical trial program). The ADVANCE trials randomized more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin, to assess the safety and efficacy of Eliquis.
In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.