FDA Approves Eliquis to Reduce the Risk of Blood Clots

Bristol-Myers Squibb and Pfizer reported that FDA approved 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 patients who have undergone hip or knee replacement surgery. 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 5770 receiving Eliquis and 5755 receiving enoxaparin, to assess the safety and efficacy of Eliquis.

In December 2013, 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.

Source: Pfizer