FDA Approves New Option for Prevention of Venous Thromboembolism
The FDA has approved betrixaban (Bevyxxa, Portola) for the prophylaxis of venous thromboembolism (VTE) in adults who are hospitalized for acute medical illness and at risk for thromboembolic complications due to moderate or severe restricted mobility and other VTE risk factors.
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Approval of the drug was based on the results of a randomized, double-blind, multinational clinical trial comparing extended-duration betrixaban to short-duration enoxaparin for the prevention of VTE in 7513 acutely medically ill hospitalized individuals with VTE risk factors. Those taking betrixaban saw fewer events of proximal deep vein thrombosis, nonfatal pulmonary embolism, or VTE-related death (4.4%) than those taking enoxaparin (6%).
The most common adverse events with betrixaban were bleeding-related.
FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients [press release]. June 23, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564422.htm.