FDA Clears Betrixaban for VTE Prophylaxis

The FDA has approved betrixaban (Bevyxxa, Portola) for venous thromboembolism (VTE) prophylaxis 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 VTE risk factors.

In a randomized, double-blind trial comparing extended-duration betrixaban (35 to 42 days) to a short duration of enoxaparin (6 to 14 days) in acutely medically ill hospitalized patients with VTE risk factors, fewer VTE events were observed in the betrixaban than enoxaparin arm (4.4% vs. 6%). Betrixaban recipients had a 25% relative risk reduction compared with enoxaparin arm.

From the July 31, 2017 Issue of Renal and Urology News