REGULATORY STATUS

• On August 24, 2021, Janssen Pharmaceuticals, Inc received approval for XARELTO in combination with aspirin to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study.¹
• On October 11, 2019, Janssen Pharmaceuticals, Inc. received approval for XARELTO for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness and who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE not at high risk of bleeding. The approval is supported by the data from the MAGELLAN study, as well as a subpopulation of patients from MAGELLAN not at high risk of bleeding.²
• On October 11, 2018, Janssen Pharmaceuticals, Inc. received approval for XARELTO in combination with aspirin to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).² The approval is supported by the data from the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) clinical trial study.
• On June 28, 2013, Janssen Research & Development, LLC received a complete response letter from the FDA regarding a sNDA for XARELTO to reduce the risk of stent thrombosis in patients with ACS.³
• On March 4, 2013, Janssen Research & Development, LLC received a second complete response letter from the FDA regarding a supplemental New Drug Application (sNDA) for XARELTO for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS).⁴
• On November 2, 2012, Janssen Pharmaceuticals, Inc. received approval for XARELTO for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment.⁵ On October 27, 2017, Janssen Pharmaceuticals, Inc. received approval for the new dosing regimen of 10 mg once daily for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for DVT and /or PE after completion of initial treatment lasting 6 months.⁵
• On November 4, 2011, Janssen Pharmaceuticals, Inc. received approval for XARELTO to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.² The approval is supported by data from the ROCKET AF (Rivaroxaban, Once-daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) clinical trial study.⁶
• On July 1, 2011, Janssen Pharmaceuticals, Inc. received approval for XARELTO for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.⁵ The approval is supported by data from the RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program.⁶
• XARELTO was jointly developed by Johnson & Johnson Pharmaceutical Research and Development, L.L.C and Bayer Healthcare AG.⁶
• The approved brand name for rivaroxaban is XARELTO^®.⁶
• For additional ongoing clinical trials, visit www.clinicaltrials.gov.