Bayer HealthCare has submitted a marketing authorisation application to the EMA to extend the indication of Xarelto (rivaroxaban) to treat pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults.
The application is based on results from the EINSTEIN-PE Phase III study where Xarelto demonstrated efficacy comparable to standard options and significant lower rates of major bleeding.
Dr Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development, says the application has the “potential” to extend the benefits of Xarelto “to an even wider patient population”.
If approved by the EMA, Xarelto would become the first oral treatment for the initial treatment of PE and long-term prevention of recurrent DVT.
Xarelto is currently indicated for the VTE prevention in adults following elective hip or knee replacement surgery. It is currently used in more than 100 countries and was recently recommended in final draft guidanceby NICE for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).