Bayer’s oral anticoagulant Xarelto has been submitted for EU marketing authorisation for the treatment of pulmonary embolism and the prevention of recurrent deep vein thrombosis.
Xarelto has already been approved by the European Commission for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT in adults.
The submission is supported by data from the pivotal, global Phase III Einstein-PE study, which compared the oral single drug approach of Xarelto (rivaroxaban) 15mg twice daily for three weeks followed by 20mg once daily with the current standard of care, subcutaneous enoxaparin followed by a VKA.
According to the study, Xarelto demonstrated efficacy comparable to that of the current standard therapy in reducing the primary end point of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis and non-fatal or fatal PE. Xarelto was associated with a significant 50% relative risk reduction in major bleeding events.
“Pulmonary embolism is one of the most severe events in thrombotic medicine. The EMA submission of rivaroxaban for the treatment of PE and the prevention of recurrent DVT represents another step towards providing patients and the NHS with a single drug solution in this indication,” said Luis Felipe Graterol, medical director at Bayer HealthCare UK.
Einstein-PE is one of three Phase III studies in the global Einstein programme that evaluated the safety and efficacy of Xarelto in the treatment of venous thromboembolism in almost 10,000 patients.