Bayer HealthCare receives new EU approval for Xarelto

Bayer HealthCare has announced that its multipurpose anticoagulant Xarelto has been approved in another new indication by the European Commission.

The drug has been ratified for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis and PE in adults, making it the only novel oral anticoagulant approved for this indication.

Findings from the phase III Einstein-PE study showed that the drug delivered comparable efficacy to the current standard of care, while significantly reducing the associated risk of major bleeding events.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "This new approval will bring the benefits of Xarelto to more patients and physicians, where the need for a fast, effective and convenient therapy against blood clots is essential for both acute and long-term treatment."

This builds on Xarelto's status as the most broadly indicated new oral anticoagulant available on the market, with more than 2.5 million patients having received the drug in daily clinical practice since its 2008 debut.

Earlier this month, Bayer HealthCare initiated a new Xarelto study assessing the product as a therapy for coronary artery disease and peripheral artery disease.