FDA Approves Betrixaban for VTE Prophylaxis

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 to 42 days, followed by a placebo injection once-daily for 6 to 14 days) or short-duration enoxaparin (enoxaparin 40 mg subcutaneously once-daily for 6 to 14 days followed by an oral placebo pill once-daily for 35 to 42 days).

Patients in the betrixaban arm experienced fewer VTE events, a composite outcome score of 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).

Fifty-four percent of betrixaban-treated patients experienced at least one adverse event (AE), compared with 52 percent of those on enoxaparin. The most common AEs (observed in ≥5% of patients) associated with betrixaban were bleeding-related, and bleeding was the most common reason for treatment discontinuation.

Source: FDA news release, June 23, 2017.