By RTT News,
August 21, 2014, 02:00:00 PM EDT
(RTTNews.com) - Bristol-Myers Squibb Co. ( BMY ) and Pfizer Inc. ( PFE ) said Thursday that the U.S. Food and Drug Administration has approved a Supplemental New Drug Application for Eliquis for the treatment of deep vein thrombosis and pulmonary embolism, and for the reduction in the risk of recurrent DVT and PE following initial therapy.
Combined, DVT and PE are known as VTE. It is estimated that every year, about 900,000 Americans are affected by DVT and PE.
The full prescribing information for Eliquis includes Boxed Warnings for the increased risk of thrombotic events in patients who prematurely discontinue Eliquis; 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.
Eliquis increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
The FDA approval of Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy, is based on data from the global AMPLIFY and AMPLIFY-EXT studies.
Eliquis is also indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Additionally, Eliquis is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery.
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