Thrombosis.TV Breaking Update: Betrixaban Approved by the FDA Alpesh Amin MD, MBA, MACP, SFHM, FACC University of California, Irvine

Betrixaban’s Indication BEVYXXA is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE

Standard Prophylaxis* Standard Prophylaxis* APEX Study Design Efficacy Evaluation Standard Prophylaxis* 10 ± 4 days Standard Prophylaxis* 10 ± 4 days Extended Prophylaxis 35 – 42 days Extended Prophylaxis 35 – 42 days Enoxaparin 40 mg Placebo Ultrasound & Visit 3 35-42 days Subjects enrolled (N=7,513) R 1:1 Double blind, double dummy Betrixaban 80 mg† Betrixaban 80 mg Loading dose 160 mg Cohen A et al. N Engl J Med 2016;375:534-44.

Primary Endpoint Reductions Incidence (%) (95% CI 0.63-0.92) P=0.006 Cohen A et al. N Engl J Med 2016;375:534-44.

KM Estimates for 80mg Betrixaban vs Placebo Gibson M et al. Am Heart J 2017;185:93-100

FDA Analysis of Efficacy

Which type of patients in the hospital are at risk for VTE? Question: Which type of patients in the hospital are at risk for VTE?

Question: Why is it important to have an oral alternative to LMWH in this patient population?

Question: Which dose is approved and in general, how long should patients be treated for?