The Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban; Portola) for the prophylaxis of venous thromboembolism (VTE) in adults 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.
The approval was supported by data from a randomized, double-blind, multinational clinical trial (n=7,513), APEX, that evaluated extended-duration Bevyxxa (35–42 days) vs. short-duration enoxaparin (6–14 days) for VTE prevention in acutely medically ill hospitalized patients at risk for VTE.
Patients were randomized to Bevyxxa 160mg orally on Day 1 then 80mg once daily for 35–42 days with a placebo injection once daily for 6–14 days or enoxaparin 40mg subcutaneously once daily for 6–14 days with a placebo pill once daily for 35–42 days.
The study examined efficacy in 7,441 patients according to a composite outcome score consisting of either the occurrence of asymptomatic or symptomatic proximal deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE), or VTE-related death. Patients in the Bevyxxa arm had fewer events vs. patients in the enoxaparin arm (4.4% vs. 6.0%, relative risk [RR] 0.75, 95% CI: 0.61, 0.91).
Regarding safety, the most common adverse events associated with Bevyxxa were related to bleeding. A similar proportion of patients experienced at least one adverse reaction in both arms: 54% Bevyxxa vs. 52% enoxaparin. The incidence rate for all bleeding events was 2.4% in the Bevyxxa arm vs. 1.2% in the enoxaparin arm; major bleeding events was seen in 0.67% of Bevyxxa vs. 0.57% of enoxaparin.
Bevyxxa, an oral factor Xa (FXa) inhibitor, selectively blocks the active FXa site and does not require a cofactor for activity. By directly inhibiting free FXa, it decreases thrombin generation; it has no effect on platelet aggregation.
Bevyxxa carries a Boxed Warning regarding the risk of epidural or spinal hematomas in patients treated with betrixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These risks should be considered when scheduling patients for spinal procedures.
Bevyxxa will be available as 40mg and 80mg strength capsules in 100-count bottles.
For more information call (855) 767-7167 or visit Portola.com.