Betrixaban approved as oral VTE preventive.

Abstract

FDA and Portola Pharmaceuticals on June 23 announced the approval of betrixaban oral capsules to reduce the risk of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who have restricted mobility or other risk factors for thromboembolic complications. The anticoagulant will be made available between August and November 2017 under the brand name Bevyxxa, according to Portola. Betrixaban will be supplied as 40- and 80-mg capsules in bottles of 100 each that should be stored at room temperature. Betrixaban’s labeling describes the drug as a factor Xa inhibitor that blocks its target site without the need for a cofactor. Treatment with betrixaban decreases thrombin generation and does not directly affect platelet aggregation. FDA stated that it approved the drug on the basis of data from the Acute Medically Ill VTE Prevention With Extended Duration Betrixaban (APEX) trial. The APEX trial compared thromboembolic event and death rates in acutely ill patients treated with betrixaban capsules for 35–42 days or subcutaneously administered enoxaparin for 6–14 days. All study participants had been hospitalized for heart failure, respiratory failure, infection without septic shock, rheumatic disorders, or ischemic stroke.