FDA Approves Betrixaban for Venous Thromboembolism

The U.S. Food and Drug Administration (FDA) has approved betrixaban for the prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who are at risk for thromboembolic complications (related to limited mobility or other risk factors for VTE). Betrixaban is now the fifth FDA-approved oral anticoagulant on the market.

The decision was based on data from the phase III APEX trial – a double-blind, international study that randomized 7,513 patients to receive either extended-duration betrixaban (betrixaban 160 mg orally on day 1, then 80 mg daily for 35-42 days, followed by a placebo injection once-daily for 6-14 days) or short-duration enoxaparin (enoxaparin 40 mg subcutaneously once-daily for 6-14 days followed by an oral placebo pill once-daily for 35-42 days).

Patients in the betrixaban arm experienced fewer VTE events (including asymptomatic or symptomatic proximal deep vein thrombosis, non-fatal pulmonary embolism, or VTE-related death): 4.4 percent versus 6 percent (relative risk = 0.75, 95% CI 0.61-0.91).
One or more adverse events (AEs) occurred in 54 percent of patients receiving betrixaban, compared with 52 percent receiving enoxaparin. The most common AEs (observed in ≥5% of patients) associated with betrixaban were involved bleeding. Treatment discontinuation related to AEs was reported in 2.4 percent of patients receiving betrixaban and 1.2 percent of patients receiving enoxaparin, and bleeding was the most common reason for treatment discontinuation.

Source: U.S. Food and Drug Administration news release, June 23, 2017.

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