The FDA has approved anticoagulant betrixaban, sold under the name Bevyxxa, for the prevention of venous thromboembolism (VTE) in acutely ill patients, reports Medscape.
Betrixaban is the first and only anticoagulant for hospital and extended-duration prophylaxis (35 to 42 days) of VTE in this patient group, the company said in a news release.
The FDA granted betrixaban fast-track designation and priority review.
Its approval was based on data from the pivotal phase 3 APEX study. The randomized, double-blind, multinational clinical trial compared extended-duration betrixaban (35 to 42 days) to short-duration enoxaparin (Lovenox, Sanofi) (6 to 14 days) for VTE in 7513 acutely medically ill hospitalized patients with VTE risk factors.
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