FDA Approves VTE Prevention Drug Betrixaban

The US Food and Drug Administration (FDA) has approved BEVYXXA (betrixaban) for the prophylaxis of venous thromboembolism (VTE) in hospitalized acute medical illness adult patients who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

The treatment, produced by Portola Pharmaceuticals, was approval based on data from a randomized, double-blind, multi-national clinical trial.

The trial compared extended duration betrixaban (35-42 days) to short duration of enoxaparin (6-14 days) in the prevention of VTE in a hospitalized population at risk for the condition.

The trial randomized 7,513 patients to either betrixaban or enoxaparin treatment. Patients on the betrixaban arm took an initial dose of 160 mg orally on day 1, then 80 mg once daily for 35-42 days. They also received a placebo injection once daily for 6-14 days.

Patients on enoxaparin received 40 mg subcutaneously once daily for 6-14 days, and took a placebo pill orally once daily for 35-42 days.

Treatment efficacy was measured by a composite outcome score comprised of either the occurrence of asymptomatic or symptomatic proximal deep vein thrombosis, non-fatal pulmonary embolism, or VTE-related death. Fewer events were observed in patients receiving betrixaban (4.4%) versus enoxaparin patients (6%).

Over 50% of patients receiving either treatment at least one adverse reaction, with bleeding-related incidences being the the most common adverse reactions with betrixaban. The frequency of patients reporting serious adverse reactions was similar between betrixaban (18%) and enoxaparin (17%). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4% and 1.2% for betrixaban and enoxaparin, respectively.

The FDA recommends an initial single dose of 160 mg of betrixaban starting on day 1, followed by 80 mg once daily taken for 35-42 days at the same time each day with food.

A press release regarding the approval was made available.

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