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

2. 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

3. 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:

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

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

6. FDA Analysis of Efficacy

7. 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?

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

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