The US Food and Drug Administration (FDA) has approved the new oral anticoagulant betrixaban (Bevyxxa, Portola) for venous thromboembolism (VTE) prophylaxis in hospitalized, acutely medically ill patients at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
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.
Patients in the betrixaban group took an initial dose of 160 mg orally on day 1, followed by 80 mg once daily for 35 to 42 days, and received a placebo injection once daily for 6 to 14 days. Patients in the enoxaparin group received 40 mg subcutaneously once daily for 6 to 14 days and took a placebo orally once daily for 35 to 42 days.
Efficacy was measured in 7441 patients using a composite outcome score composed of the occurrence of asymptomatic or symptomatic proximal deep-vein thrombosis, nonfatal pulmonary embolism, or VTE-related death.
Fewer of these events were seen in patients receiving betrixaban (4.4%) than in those taking enoxaparin (6%) (relative risk, 0.75; 95% confidence interval, 0.61 - 0.91).
The most common adverse reactions (in ≥5%) with betrixaban were related to bleeding. Overall, 54% of patients receiving betrixaban experienced at least one adverse reaction compared with 52% taking enoxaparin, the FDA notes. There was no difference in the frequency of patients reporting serious adverse reactions: 18% with betrixaban and 17% with enoxaparin.
The most common reason for discontinuing treatment was bleeding, with an incidence rate for all bleeding episodes of 2.4% for betrixaban and 1.2% for enoxaparin. The incidence rate for major bleeding episodes was 0.67% and 0.57%, respectively.
Betrixaban represents a "major advance for the field of thrombosis. It is the first therapy to demonstrate a reduction in the incidence of VTE in these high-risk patients without a significant increase in major bleeding," APEX investigator C. Michael Gibson, MD, professor at Harvard Medical School in Boston, Massachusetts, said in the company news release.
The recommended dose of betrixaban is an initial single dose of 160 mg starting on day 1, followed by 80 mg once daily taken for 35 to 42 days at the same time each day with food.
The company said it expects to launch Bevyxxa between August and November of this year.
Full prescribing information is available online.
Cite this: FDA Clears Betrixaban (Bevyxxa) for VTE Prophylaxis - Medscape - Jun 23, 2017.
Comments