Bayer HealthCare submits new European Xarelto filing

Bayer HealthCare has submitted a new European regulatory filing for its multipurpose oral anticoagulant Xarelto.

A marketing authorisation application has been filed with the European Medicines Agency for approval of Xarelto as a treatment for pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults.

This submission is supported by data from the recent successful Einstein-PE clinical trial, which showed the potential safety and efficacy of the drug in this indication among more than 4,800 patients.

Bayer's rivaroxaban-based therapy option is already approved across most of the major venous and arterial thromboembolic areas.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "The current filing for the treatment of PE and prevention of recurrent VTE has the potential to further extend the benefits of rivaroxaban to an even wider patient population."

Xarelto has been earmarked by Bayer as having the potential to become a billion-dollar blockbuster seller.