Bayer's Xarelto gets label update in Europe

German drug major Bayer (BAYN: DE) has updated the label for its Xarelto (rivaroxaban) in Europe.

This update provides physicians with information based on the positive European Medicines Agency/Committee for Medicinal Products for Human Use (CHMP) opinion from December 2014, and refers to the clinical utility of the drug in patients with non-valvular atrial fibrillation who require cardioversion. This makes Xarelto the only novel oral anticoagulant with specific label guidance for early and delayed conversions.

The label change is based on findings from the X-VeRT study, which showed that, compared with the use of vitamin K antagonists, rivaroxaban was associated with a reduction in the risk of cardiovascular events of 50% in the primary efficacy outcome of stroke, transient ischemic attack, peripheral embolism, myocardial infarction and cardiovascular death. The practical advantage of using rivaroxaban was demonstrated by the shorter time to cardioversion compared to vitamin K antagonist, particularly in patients scheduled for delayed cardioversion.