Venous Thromboembolism Prevention Therapy Receives FDA Approval

The FDA recently approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism (VTE) among patients who are at risk of the complication, according to a press release. Betrixaban was previously granted fast track designation and was approved under priority review.

Betrixaban is a once-daily Factor Xa inhibitor and is indicated to treat patients who were hospitalized for an acute illness and have restricted mobility or other risk factors that may cause VTE.

Patients who are hospitalized for acute medical illness may have experienced heart failure, stroke, infection, and pulmonary disease. Due to these conditions and immobilization, they have an increased risk of developing blood clots, according to the release.

The new approval was based on positive findings from the phase 3 APEX clinical trial. The investigators assessed the ability of long-term treatment (35 to 42 days) with betrixaban and short-term treatment (6 to 14 days) with enoxaparin in preventing VTE among 7513 patients.

"Bevyxxa 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,” said C. Michael Gibson, MD, executive committee member of the APEX trial. “With this approval, we are finally able to help protect these patients from this often fatal, yet preventable condition.”

Patients were randomized to receive either treatment plus placebo. Patients treated with betrixaban received an initial dose of 160-mg on day 1, then 80-mg once per day for 35 to 42 days and received a placebo injection once per day for 6 to 14 days. Patients treated with enoxaparin received 40-mg subcutaneously once per day for 6 to 14 days and took a placebo pill orally once per day for 35 to 42 days.

The investigators assessed efficacy by a composite score that included the occurrence of proximal deep vein thrombosis, non-fatal pulmonary embolism, or VTE-related death, according to the study.

The researchers discovered that only 4.4% of patients treated with betrixaban experienced the events, while 6% of patients treated with enoxaparin experienced the events, the FDA reported.

Patients treated with betrixaban commonly experienced adverse reactions related to bleeding. The frequency of serious adverse reactions was similar between the treatments, with 18% in the betrixaban group and 17% among the enoxaparin group.

Portola Pharmaceuticals expects to launch betrixaban between August and November 2017, according to a press release.

“For the first time, physicians will have a therapy to help reduce VTE in acutely ill medical patients during their transition from hospital to home, which may ultimately help reduce morbidity,” said Alexander T. Cohen, MBBS, MSc, MD, FRACP, co-principal investigator and co-chairman of the APEX executive committee.