Portola (PTLA) announced that the U.S. Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban), the first anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Bevyxxa’s approval is on data from Portola's pivotal Phase 3 APEX Study, which enrolled over 7,500 patients and conducted the tests at more than 450 clinical sites around the world
Michael Gibson, M . . .