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FDA approves BevyxXa for prevention of venous thromboembolism
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The FDA granted approval to betrixaban for the prevention of venous thromboembolism and pulmonary embolism in acutely ill patients who are not undergoing surgery.
Betrixaban (BevyxXa, Portola) — an anticoagulant drug which acts as a direct Factor Xa inhibitor — is intended for 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 included data from the randomized, double blind, multinational APEX clinical trial, which compared an extended betrixaban treatment (35 to 42 days) with a shorter duration of enoxaparin (Lovenox, Sanofi) treatment (6 to 14 days) in 7,513 patients.
Researchers randomly assigned patients to receive an initial dose of 160 mg betrixaban orally on day 1, followed by 80 mg once daily for 35 to 42 days, and a placebo injection once daily for 6 to 14 days; or 40 mg enoxaparin subcutaneously once daily for 6 to 14 days and a placebo pill orally once daily for 35 to 42 days.
Of the 7,441 patients evaluated for efficacy, asymptomatic or symptomatic proximal deep vein thrombosis–, nonfatal PE–, or VTE–related death occurred in fewer patients assigned betrixaban than enoxaparin (4.4% vs. 6%; relative risk = 0.75; 95% CI, 0.61-0.91).
Serious adverse events appeared similar between arms.
Major bleeding events occurred in 0.67% of patients in the betrixaban arm and 0.57% of patients in the enoxaparin arm.
The FDA recommended an initial single dose of 160 mg betrixaban starting on day 1, followed by 80 mg once daily taken for 35 to 42 days at the same time each day with food.