The approval was based on the results of the ENGAGE AF‐TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48) and Hokusai‐venous thromboembolism (VTE) randomized controlled clinical trial. The gene discussed is F10; the disease is atrial fibrillation.