BRIEF—European label for Xarelto extended to include serious blood clotting

Germany’s Bayer and New Jersey, USA-based Johnson & Johnson have won European approval for an extended label for oral Factor Xa inhibitor Xarelto (rivaroxaban).

The new label will include a 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism (VTE), for certain patients.

Principal investigator Alexander Cohen said: “In the past there has been uncertainty about how to manage ongoing anticoagulation therapy, but this announcement means we can confidently treat high risk patients and reduce the number of VTE-related deaths, while improving the lives of those who live under the constant threat of a recurrent VTE.”

The decision was made based on data from the Phase III EINSTEIN CHOICE study.