Bristol-Myers Squibb and Pfizer announced that the FDA has 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.
The sNDA approval is based on data from 3 studies of the ADVANCE clinical trial program. This program randomized over 11,000 patients, with 5,770 receiving Eliquis and 5,775 receiving Enoxaparin (marketed as Lovenox) to assess its safety and efficacy.
Eliquis, a Factor Xa inhibitor, is already approved to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). Eliquis is also currently under FDA review for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.
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